Supportive Care in Cancer

, Volume 14, Issue 9, pp 928–935

Pilot study of a self-administered stress management and exercise intervention during chemotherapy for cancer

Authors

    • School of Physical TherapyUniversity of South Florida College of Medicine
  • Lindsay A. Taliaferro
    • H. Lee Moffitt Cancer Center and Research Institute
  • Paul B. Jacobsen
    • H. Lee Moffitt Cancer Center and Research Institute
Original Article

DOI: 10.1007/s00520-006-0021-1

Cite this article as:
Wilson, R.W., Taliaferro, L.A. & Jacobsen, P.B. Support Care Cancer (2006) 14: 928. doi:10.1007/s00520-006-0021-1

Abstract

Goals of work

This pilot project explored the feasibility, safety, and effectiveness of a self-administered exercise and stress management intervention for cancer patients receiving chemotherapy.

Patients and methods

Thirty-nine of 56 eligible patients (acceptance =69%) with a variety of solid tumors volunteered for the study. Participants were advised to exercise 20–40 min at 50–75% estimated heart rate reserve 3–5 times per week. In addition, patients were provided with instruction and written materials regarding stress management techniques. Follow-up data were collected during regularly scheduled outpatient visits at the start of the second, third, and fourth chemotherapy cycles using diary entries and the same questionnaires previously administered at baseline.

Main results

Twenty-four of 39 patients (62%) completed all study requirements. These participants completed 438 of the 678 exercise sessions assigned (adherence =62%). Of the stress management techniques, positive thinking most practiced most frequently (48%), followed by deep breathing (38%) and active relaxation (37%). Paired t tests, comparing baseline values with final recorded values, indicated a significant improvement over time in bodily pain (p<0.03) and mental health (p<0.04) subscale scores. Participants’ evaluations of the combined intervention were favorable: 90% felt it was helpful to them and 100% would recommend it to another patient.

Conclusions

A self-administered intervention combining aerobic exercise and stress management was acceptable and safe for cancer patients receiving chemotherapy. Preliminary data demonstrating intervention efficacy should be confirmed in subsequent randomized clinical trials.

Background

The adverse effects of chemotherapy treatment on quality of life are well documented. Cancer patients undergoing chemotherapy experience a number of symptoms (e.g., nausea, vomiting, fatigue, and sleep disturbance) and physical limitations (e.g., task performance and activity restrictions) that are accompanied by declines in physical and mental well-being.

Randomized clinical trials (RCTs) have generally shown that stress management training and exercise training are effective in improving quality of life in these patients. A recent metaanalysis of stress management interventions for people treated for cancer, including nine randomized clinical trials focusing on chemotherapy patients, confirmed the beneficial effects of these interventions in improving mental health and relieving symptoms [14]. This research demonstrated that a variety of professionally administered interventions, including progressive muscle relaxation training with guided imagery [3, 15], systematic desensitization [22], and biofeedback [6] were effective in relieving nausea, vomiting, and emotional distress in the period just before chemotherapy. Some of the same interventions were also found to have beneficial effects in the hours and days following chemotherapy administration [15, 22].

A review of the literature also identified six published randomized clinical trials (RCTs) of exercise interventions for cancer patients receiving standard dose chemotherapy in outpatient settings [16, 18, 20, 25, 29, 30]. In all these studies, participation was limited to women with breast cancer. Observed benefits of these exercise programs (i.e., significant differences relative to control conditions) include increased physical capacity [16], decreased body fat [30], decreased nausea [29], decreased fatigue [20], and improved physical functioning [25]. The possibility that a combined approach may have greater effects than either intervention alone is suggested by one study that combined an exercise intervention with biweekly support groups for chemotherapy outpatients [18]. In that study, the experimental group (n=9) demonstrated greater physical performance, better psychosocial adjustment, and less fatigue, depression, and sleep problems relative to the control group (n=5).

In the studies cited above, the interventions were typically delivered by a mental health or physical rehabilitation professional on an individual basis. Widespread availability of interventions delivered in this manner is unlikely due to the limited number of qualified health professionals working in oncology settings as well as the potentially prohibitive costs of using mental health and physical rehabilitation professionals as interventionists. However, the success of those studies has encouraged Investigators to modify the delivery of stress management and exercise interventions to make them more accessible to chemotherapy outpatients [7, 12, 21, 25]. In one effort to enhance access, Carey and Burish [7] developed a behavioral treatment for chemotherapy-induced nausea and vomiting that could be delivered by oncologists and oncology nurses and compared its efficacy to the same treatment delivered by psychologists and a no intervention control condition. Administration of the behavioral treatment (systematic desensitization) required patients to be seen on an individual basis for two 1-h sessions. Delivery of the intervention by oncology professionals was found to be as effective as delivery by psychologists and superior to no intervention in relieving anticipatory nausea, anticipatory vomiting, and posttreatment nausea [4]. Despite these positive findings, widespread adoption of this approach is unlikely due to the amount of professional time still required to deliver the intervention.

We previously evaluated two forms of stress management training: professionally administered and patient self-administered [12]. Each form provided instruction in three techniques (abdominal breathing, progressive muscle relaxation training with guided imagery, and coping self-statements) found to be effective in improving quality of life in a variety of clinical populations [8, 11, 17]. In the professionally administered form, training was provided during a single 60-min session conducted by a mental health professional. In the patient self-administered form, training was provided via a package of educational resources distributed by a mental health professional. Both forms of stress management training were expected to result in improved quality of life over the course of chemotherapy relative to a usual care only control condition. However, only the self-administered form was found to be superior to usual care in improving quality of life. Moreover, the costs of this intervention were estimated to be up to 68% less than the average costs of other professionally administered stress management interventions for chemotherapy patients.

Similarly, a randomized exercise trial conducted by Segal et al. [25] evaluated supervised, and self-directed walking interventions for women undergoing adjuvant hormonal therapy, radiotherapy, or chemotherapy for early stage breast cancer. Outcomes assessed included self-reported quality of life (SF-36) and aerobic capacity (modified Canadian Aerobic Fitness Test). Among the 83 patients receiving chemotherapy, the only significant (p<0.05) difference found among SF-36 subscale scores between the control and experimental groups was on the physical functioning scale. Results indicated that the self-directed group, but not the supervised group, outscored the usual care control group.

The findings reviewed above suggest that self-administered forms of both stress management and exercise training may be more effective for improving quality of life for chemotherapy patients than professionally administered forms. Moreover, an intervention which combines stress management training with exercise training might yield improvements across a broader array of quality of life domains than either form of training alone. In other words, it may be possible to combine the benefits to mental well-being observed with stress management training with the benefits to physical health observed with exercise training. Beyond this, it is possible that the benefits of combining the two forms of training may be synergistic and not just additive. That is, the benefits of a combined intervention to mental health may be greater than the benefits of stress management training alone and the benefits to physical health may be greater than the benefits of exercise training alone [2].

We present results from a pilot study of a self-administered intervention combining stress management training and a home-based exercise program for cancer patients about to begin chemotherapy treatment. The specific aims of this study were: (1) to evaluate the acceptability of a combined stress management-exercise intervention to cancer patients beginning chemotherapy treatment; (2) to evaluate the safety of a home-based exercise intervention for cancer chemotherapy patients; (3) to estimate adherence to exercise recommendations among patients participating in an evaluation of a home-based exercise intervention; and (4) to obtain preliminary data regarding the potential efficacy of a combined stress management-exercise regimen for improving quality of life for cancer chemotherapy patients.

Materials and methods

Participants

To be eligible for the study, participants were required to: (1) be >18 years of age; (2) have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia or psychosis); (3) be capable of speaking and reading standard English; (4) be diagnosed with a nonmetastatic (< stage 4) form of cancer; (5) have no previous experience with intravenous chemotherapy administration prior to study recruitment; (6) be scheduled to receive four or more cycles of intravenous cytotoxic chemotherapy at H. Lee Moffitt Cancer Center; (7) not be scheduled to receive radiation treatment during the first 12 weeks of chemotherapy treatment; (8) have no contraindications to participating in moderate intensity exercise (see below) as determined by their attending oncologist and the research staff; and (9) be able to provide informed consent.

Patients who met all the demographic, disease, and treatment eligibility characteristics listed above and whose medical charts indicated that they did not have any of the following conditions were invited to participate: active infections, cardiomyopathy, congestive heart failure, nervous system dysfunction causing sensorimotor deficits significant enough to impede unassisted walking, anemia (Hgb <8 g/dl), neutropenia (absolute neutrophil count <0.05×109/l), bony metastases involving >25% of the cortex at any site by radiograph, severe pulmonary or ventilatory disease (FEV 1.0<50%), large pleural effusions or pericardial effusions (radiological evidence), severe osteoporosis (>2.5 SD), thrombocytopenia (platelets <25×109/l), hyponatremia (Na+ <130 mmol/l), hypokalemia (K+ <3.0 mmol/l), or abnormal ECG (recent preventricular contractions, fast atrial arrhythmias, ventricular arrythmias, or ischemic pattern). These criteria are consistent with precautions and contraindications for exercise following cancer diagnosis recently articulated by Courneya et al. and published by the American College of Sports Medicine [9].

Procedures

Patients not excluded from participation based on medical chart review were discussed briefly with their attending oncologist to review any other possible contraindications to study participation. Patients who met all eligibility criteria and whose oncologists signed the clearance form were introduced to a member of the research team who explained the study to the patient and obtained written informed consent for participation.

Baseline assessment occurred before the start of chemotherapy and intervention delivery for patients who agreed to participate. We assessed the following demographic variables via chart review or self-report: age, race/ethnicity, marital status, education, occupation, employment status, and income. In addition, the following clinical variables were assessed via medical chart review at either time of recruitment or study completion (as appropriate): date of cancer diagnosis, type of cancer, disease stage, and hospitalizations during the course of study participation (admission and discharge dates, reasons). Participants also completed a self-report measure of health-related quality of life at the baseline assessment (see “Measures” below).

To document any potential safety issues or adverse events possibly related to exercise training during chemotherapy treatment, participants were asked to review a checklist of possible symptoms or events that could be attributed to exercise training at each follow-up assessment. The list includes possible symptoms of overtraining (e.g., insomnia on exercise days), adverse events or symptoms that may make it advisable to temporarily discontinue exercising (e.g., sprains, falls, muscle cramps, or dizziness), as well as conditions that place participants at increased risk for dehydration or electrolyte imbalance (e.g., episodes of vomiting or diarrhea). Participants were provided with diary forms with which to record daily practice of the three identified stress management techniques. Respondents were also asked to record the following information for each exercise session: date, time duration, resting heart rate, exercise heart rate, and subjective exercise response.

Upon returning to clinic for the first chemotherapy treatment, participants met briefly (5–10 min) with the same interventionist seen previously. The purpose of this meeting is to answer any questions about the intervention, to encourage completion of diary forms, to review adherence to recommendations for use of exercise and stress management techniques, to discuss the importance of adhering to recommendations, to identify and address any barriers to the use of the techniques, and to monitor for any adverse reactions to the use of the techniques. Diary contents were reviewed to monitor and promote adherence to the intervention and to adjust the frequency and intensity of exercise sessions to suit individual responses. The self-report measure of health-related quality of life was also readministered during this meeting.

Similar brief meetings and assessments were conducted in the clinic just before the start of the second, third, and fourth chemotherapy treatment cycle. If a participant received only three cycles of chemotherapy, the final assessment was timed to coincide with the estimated date of the start of a fourth treatment cycle. By scheduling the final follow-up assessment for just before the start of the fourth treatment cycle, we anticipated that 10–13 weeks would have elapsed because of baseline assessment and randomization to intervention conditions. This interval was judged sufficient to observe exercise related changes in fitness and quality of life outcomes [1, 9].

Measures

Health-related quality of life

The Medical Outcomes Study 36-Item Short Form (SF-36) was the primary outcome measure in this study. The SF-36 is a widely used self-report measure designed to assess perceived health and functioning [28, 29]. The validity and reliability of the SF-36 has been established in a number of clinical populations, including cancer patients [27].

Interventions

Self-administered stress management training

The stress management training used in the current study is the same intervention used in a randomized clinical trial we conducted with chemotherapy patients [12]. As in our previous study, participants received a packet of materials from the study interventionist, along with a brief (5–10 min) standardized introduction to the self-administered intervention. The packet of materials consisted of a videotape, audiotape, and brochure. Participants were instructed to first view the 15-min videotape and then follow directions in the brochure regarding further training, practice, and use of stress management techniques. The videotape and booklet discuss the sources and manifestations of stress during chemotherapy and the potential benefits of using stress management techniques during chemotherapy treatment. The videotape and brochure also provide brief instruction in paced abdominal breathing, progressive muscle relaxation with guided imagery, and the use of coping self-statements, as well as recommendations for practicing the techniques before the start of chemotherapy and using them after the start of chemotherapy. Testimonials about the benefits of stress management training provided by chemotherapy patients are interspersed throughout the videotape and brochure.

The paced breathing exercise follows a format similar to the one developed by Turk et al. [26]. Participants were instructed to imagine that their abdomen is a balloon that inflates as they inhale and deflates as they exhale. Once the abdominal breathing skill was developed, participants were guided through a paced breathing exercise designed to induce a sense of relaxation. The progressive relaxation and guided imagery exercise used a format similar to the one developed by Burish et al. [5]. Using the accompanying audiotape, participants were directed to repeatedly tense and relax a standard set of muscle groups, after which they were guided through the visualization of a tranquil nature scene to enhance and sustain feelings of relaxation. The use of coping self-statements followed a format similar to the one developed by Meichenbaum as part of stress inoculation training [17]. Participants were instructed to stop when they sense themselves experiencing symptoms of stress, to think about negative things they might be saying to themselves about their ability to cope, and to focus instead on more positive things they might say to themselves about coping with stress. As part of this exercise, participants were encouraged to identify specific coping self-statements they used during chemotherapy treatment. Participants were provided with a toll-free telephone number to call if they had questions.

Home-based exercise intervention

The aerobic exercise intervention used in the current study is informed by precautions and considerations for exercise following cancer diagnosis and recommendations for home-based exercise published by the American College of Sport Medicine [1, 9]. Participants were instructed to follow the directions for exercise training in an exercise instruction booklet plus those added by the interventionist before and after the start of chemotherapy treatment. The booklet discusses the rationale and potential benefits of engaging in regular exercise while undergoing chemotherapy treatment. The emphasis is on walking, as previous research with chemotherapy patients has demonstrated relatively high rates of adherence and quality of life benefits with such programs [10, 20, 24, 25]. Alternative modes of exercising (e.g., swimming or cycling) were allowed if preferred by participants

Following the explanation of the intervention, the interventionist provided initial recommendations for exercise to each participant based on their recent exercise history (i.e., 50–75% age-predicted heart rate reserve). The initial exercise prescription was written onto the diary forms distributed to participants who were also provided with a toll-free telephone number to call if they had questions about the intervention.

Data analysis

To evaluate the acceptability of a home-based exercise and stress-management intervention to cancer patients beginning chemotherapy treatment, we computed the percentage of eligible patients who agreed to participate in the study as evidenced by the signing of an informed consent form. A total participation rate of 60% or greater was considered evidence of sufficient acceptability of the intervention as currently designed. Safety of the home-based exercise intervention was evaluated by examining the number and type of adverse events reported by participants and/or noted by the interventionist at each follow-up assessment.

To estimate adherence to exercise recommendations among patents participating in an evaluation of a home-based exercise intervention, we computed the mean percentage of recommended exercise (number of recommended sessions multiplied by recommended time for each session) that participants report completing. An adherence rate of 75% of recommended exercise was considered evidence of sufficient adherence for the intervention as currently designed.

Paired t tests were conducted comparing baseline values with final recorded values for each participant to assess the potential efficacy of the intervention. The outcome measures for these analyses were the mental physical component summary scales of the SF-36 and scores on the eight SF-36 subscales. As part of this analysis, we also computed effect sizes for pre–post intervention changes observed in the outcome measures.

Results

Recruitment, participation, and attrition patterns are summarized in Fig. 1. Of the 56 individuals who met eligibility criteria, 39 agreed to participate (70%). The 25 women and 14 men (mean age=54 years; range=36–71) had been diagnosed with lung (n=12), breast (n=11), bladder (n=3), colon (n=2), endometrial (n=2), ovarian (n=2), testicular (n=1), prostate (n=1), kidney/renal (n=1), pancreatic (n=1), appendiceal (n=1), cervical (n=1), or rectal (n=1) cancer. Most of the participants were white (92%) and currently married (79%). Fifty-nine percent were high school graduates and 79% had an annual gross household income greater than $39,999 (Table 1).
https://static-content.springer.com/image/art%3A10.1007%2Fs00520-006-0021-1/MediaObjects/520_2006_21_Fig1_HTML.gif
Fig. 1

Participant recruitment and attrition data. Twenty-four of 39 patients (62%) completed all study requirements. These participants completed 438 of the 678 exercise sessions assigned (adherence=62%)

Table 1

Description of the sample (N=24)

Mean age

54 years

(35–70)

Female

15

(62.5%)

Caucasian

22

(92%)

Lives with spouse/partner

21

(87.5%)

AGI ≥ $40,000

19

(79%)

College graduates

14

(58%)

Five participants became ineligible after enrollment but before the initiation of the intervention because of reading difficulties (n=1), death (n=1), failure to receive treatment at Moffitt Cancer Center (n=1), absence of physician approval (n=1), or unknown (n=1). Five patients became ineligible after the intervention was initiated because chemotherapy was stopped (n=4) or progressive disease precluded further participation (n=1). Five participants chose not to complete the study. Of the 24 patients who completed all study requirements, 20 completed their final follow-up at the start of their fourth chemotherapy cycle (83%) and four completed their final follow-up at the start of their third chemotherapy cycle (17%).

Patients generally exercised by walking. The single adverse event recorded was of a patient who tripped while walking and sustained minor injuries; the patient safely resumed walking for exercise within 2 days. Adherence was calculated with regard to frequency. Of the 678 exercise sessions assigned to the 24 participants who completed the study, 438 (65%) were documented in the diaries.

Paired t tests were conducted comparing baseline values with final recorded values for each participant (Table 2). No significant improvements were observed in SF-36 Physical or Mental Component Summary Scores. However, subscale comparisons indicated a significant improvement (p<0.05) over time in SF-36 bodily pain and mental health scores. Three constructs, general health, vitality, and physical functioning changed nominally in a negative direction over time, but these declines were not significant.
Table 2

Baseline and post-intervention SF-36 component summary and subscale scores (N=24)

Measure

Baseline

Post-intervention

p

Effect size

Mean

SD

Mean

SD

SF-36 summary scales

      

 Physical component

43.79

9.33

42.96

10.57

0.72

−0.1

 Mental component

43.82

13.89

47.02

13.51

0.09

0.2

SF-36 subscale scores

      

 Physical functioning

77.43

20.65

75.52

25.77

0.65

−0.1

 Role emotional

58.33

44.23

63.89

41.61

0.38

0.1

 Mental health

66.17

22.90

75.00

23.21

0.03

0.4

 Vitality

55.21

22.34

51.25

25.12

0.30

−0.2

 Bodily pain

63.50

19.90

74.17

21.30

0.04

0.5

 Role physical

35.42

40.99

37.50

42.99

0.85

0.1

 General health

64.79

23.30

59.46

25.73

0.09

−0.2

 Social functioning

57.81

25.75

64.58

27.50

0.21

0.3

Results from postintervention questionnaires soliciting participants’ evaluations of the combined intervention were favorable: 90% felt it was helpful to them and 100% would recommend it to another patient.

Discussion

This pilot study yielded two findings. First, an intervention combining self-administered forms of stress management and aerobic exercise training appears to be feasible for use by cancer patients during chemotherapy. Our second finding was that mental health and bodily pain outcomes improved over the course of the intervention period.

We defined feasibility in terms of intervention acceptance and adherence rates. Our finding that 69% of eligible patients agreed to participate compares favorably with acceptance data from previous studies of home-based exercise conducted with chemotherapy patients. All of those studies involved women receiving chemotherapy for breast cancer, and acceptance ranged from 32–63% [20, 24, 25]. Adherence is an important methodological issue in exercise intervention trials. Exercise participation may be particularly difficult when patients are experiencing significant physical or psychosocial distress [20]. Participants in our study reported completing 62% of the assigned exercise sessions. This is consistent with previous studies of home-based exercise interventions implemented during chemotherapy treatment. In these studies, all of which again involved women with breast cancer, adherence rates ranged from 50 to 75% [10, 19, 20, 24].

Several explanations could account for the fact that, although 100% of the participants would recommend the combined intervention, only 90% found it to be useful for themselves. For example, a participant may have already been exercising or using stress management techniques at the time they entered the study. Or participants may have felt that the intervention was helpful but may have felt too ill to exercise regularly themselves. These behaviors and symptoms would not necessarily conflict with the belief that the intervention would be helpful for other patients (e.g., those who were not yet using these techniques or those who were not likely to be as ill during chemotherapy).

Our data demonstrating improved mental health are supported by several previous studies of stress management and exercise interventions during chemotherapy. A metaanalysis of 15 RCTs of stress management interventions for cancer patients (nine focusing on chemotherapy patients) confirmed the beneficial effects of these techniques for improving mental health outcomes [14]. A recent review of controlled clinical trials [13] also documented improvements in depression and anxiety accompanying exercise during chemotherapy for cancer. Previous studies have also shown that a variety of behavioral interventions, including stress management techniques, are effective for reducing acute pain associated with cancer treatment procedures. However, a recent review concluded that there is little research supporting the effectiveness of these techniques for controlling prolonged pain in patients receiving chemotherapy for cancer [23].

We did not observe improvements in physical functioning or overall health status in the present study. This finding is consistent with results from previous studies of physical exercise interventions delivered during cancer treatment. Mock et al. [19] reported that SF-36 Physical Functioning scores declined in breast cancer patients receiving adjuvant chemotherapy or radiotherapy, but this decline was less pronounced in the subgroup of patients who spent more than 90 min walking each week (48 vs 16%). Participants in our pilot study reported exercising for an average of 105 min each week and physical functioning scores declined by only 2.5%. But the absence of a control group does not allow us to examine the possibility that physical functioning or other aspects of quality of life may have declined in the absence of the combined intervention. Similarly, the absence of exercise only and stress management only comparison groups does not allow us to evaluate the possibility that additive effects are achieved when stress management and exercise interventions are implemented together.

In conclusion, this pilot study represents the first attempt to evaluate the feasibility and safety of a self-administered intervention combining stress management and exercise training during treatment for cancer. Results from our study show that the intervention was acceptable and safe for cancer patients receiving chemotherapy. While the limited sample size and the absence of comparison conditions limit conclusions that can be drawn about efficacy, we found that pain and mental health improved during the study period. These results support further evaluation of this intervention using a more rigorous design. We are currently conducting a randomized clinical trial designed to compare the relative benefits of self-administered stress management and home-based exercise training for cancer patients about to begin chemotherapy. Our goal is to determine whether a combined stress management and exercise training intervention could have a greater impact on quality of life outcomes than either intervention administered alone. Definitive evidence supporting the efficacy and cost-effectiveness of self-administered interventions could have broad implications for efforts to improve health care accessibility and clinical outcomes for cancer chemotherapy patients.

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© Springer-Verlag 2006