Maximizing Energy and Reducing Fatigue in Breast Cancer Survivors

Keywords

• self-management
• problem solving therapy
• actigraphy
• occupational therapy

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Study arms

• Experimental
  Maximizing Energy

  Maximizing Energy

  Behavioral: Maximizing Energy Intervention

• Active comparator
  Health Education

  Health Education

  Behavioral: Health Education

Interventions

• BehavioralMaximizing Energy Intervention

  A licensed occupational therapist will deliver the intervention. The Maximizing Energy program combines problem-solving therapy (PST) and energy conservation education. Participants will participate in 6 virtual once/week sessions for 30 minutes. The introductory session, they will track their fatigue and identify three key fatigue-related problems. In session 2, they will prioritize one problem and practice problem-solving steps. They then implement an action plan and review progress in the next session. If the solution is ineffective, the therapist helps modify it or create a new one. If successful, the participant moves to the next problem. A MAX workbook supports learning, covering intervention details, fatigue education, energy conservation strategies, and problem-solving worksheets. The goal is to help participants apply these strategies to improve daily life and return to work.

• BehavioralHealth Education

  To control for the effects of interactions with an interventionist, participants in the attention control group will receive the Health Education intervention. The interventionists will review a workbook covering fatigue, energy conservation, healthy eating, exercise, and relaxation. Like the MAX intervention, Health Education will be delivered virtually in weekly 30-minute one-on-one sessions for six weeks. The interventionist provides education on breast cancer-related fatigue, diet, safe physical activities, and energy conservation strategies tailored to individual needs. A workbook will support learning.

Primary outcomes

1. Retention in the study

   The proportion of participants who remain in the study until its completion relative to those initially enrolled. The retention rate will be calculated separately for the Maximizing Energy and Control Groups using the following formula: (number of participants who completed the study/number of participants initially enrolled)X 100

   Time frame: Baseline to Week 11 (4 weeks post-intervention)

2. Participant Adherence to treatment: Receipt

   The investigators will collect data on the number of intervention sessions attended by participants

   Time frame: Week 7 (post-6-week intervention)

3. Participant Adherence to treatment: Receipt

   Interventionists will rate participant's active engagement in the interventions on the Pittsburgh Participant Rating Scale. Each session will be scored 1 (no engagement, refusal) to 6 (excellent engagement) by the interventionist conducting the sessions.

   Time frame: Week 7 (post-6-week intervention)

4. Participant Adherence to treatment: Enactment

   The investigators will collect interventionist rating of whether participant completed action plan from previous session (3-point scale; 0 = not completed, 2 = plan completed) for the MAX Intervention group only.

   Time frame: Week 7(post-6-week intervention)

5. Participant Satisfaction with Intervention

   Client satisfaction is measured using the Client Satisfaction Questionnaire. The Clients Satisfaction Questionnaire is an 8-item assessment of satisfaction with the intervention program, rated on a 4-point scale that ranges from 1 to 4 in each item. Higher scores indicate greater satisfaction with the intervention.

   Time frame: Week 7(post-6-week intervention)

6. Intervention Fidelity

   All intervention sessions will be video recorded and a random 20 percent will be rated by independent evaluators trained by the principal investigator. Intervention fidelity for both groups will be assessed using the PST Provider Checklist. The a priori criterion for adequate fidelity was that equal or greater than 80 percent of intervention sessions are rated with equal or greater than 80 percent of adequate fidelity for the MAX Intervention group while less than 20 percent of intervention sessions are rated with equal or lesser than 20 percent of adequate fidelity for the Health Education group.

   Time frame: Week 7(post-6-week intervention)

7. Changes in fatigue

   The PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) is a 13-item questionnaire designed to assess fatigue levels and their impact on daily activities and quality of life. Each item is scored on a 5-point Likert scale (1 = not at all to 5 = very much), with a total score ranging from 13 to 65. Higher scores indicate greater fatigue, while lower scores suggest less fatigue and better energy levels.

   Time frame: Baseline to Week 11 (4 weeks post-intervention)

Secondary outcomes

1. Changes in resilience

   The Connor-Davidson Resilience Scale (CD-RISC) is a tool designed to measure an individual's resilience, or ability to adapt to stress and adversity. It consists of 25 items, each rated on a 5-point Likert scale (0 = not true at all to 4 = true nearly all the time), with total scores ranging from 0 to 100. Higher scores indicate greater resilience, reflecting stronger coping skills and adaptability in challenging situations.

   Time frame: Baseline to Week 11 (4 weeks post-intervention)

2. Changes in impact of fatigue in daily life

   The Modified Fatigue Impact Scale (MFIS) is a 21-item questionnaire that assesses the impact of fatigue on physical, cognitive, and psychosocial functioning. Each item is rated on a 5-point Likert scale (0 = never to 4 = almost always), with a total score ranging from 0 to 84. Higher scores indicate a greater negative impact of fatigue on daily life, while lower scores suggest minimal interference with functioning.

   Time frame: Baseline to Week 11 (4 weeks post-intervention)

3. Changes in fatigue severity

   The Fatigue Severity Scale (FSS) is a 9-item questionnaire designed to assess the impact of fatigue on daily life and functioning. Each item is rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with total scores ranging from 9 to 63. Higher scores indicate greater fatigue severity and its interference with daily activities, while lower scores suggest minimal fatigue impact.

   Time frame: Baseline to Week 11 (4 weeks post-intervention)

4. Change in physical activity: Step Count

   The investigators will collect data on physical activity as a surrogate measure of increase in energy. The ActiGraph wGT3X-BT® is a validated accelerometer used to measure physical activity outcomes, including step count. The ActiGraph wGT3X-BT will be worn on the wrist for 5 days to yield three 24 hour data for a mean number of steps taken daily.

   Time frame: Baseline to Week 11 (4 weeks post-intervention)

5. Change in Physical Activity: Energy Expenditure

   The investigators will collect data on physical activity as a surrogate measure of increase in energy. The ActiGraph wGT3X-BT® is a validated accelerometer used to measure physical activity outcomes, including energy expenditure. The ActiGraph wGT3X-BT will be worn on the wrist for 5 days to yield three 24 hour data for a mean energy expenditure daily.

   Time frame: Baseline to Week 11 (4 weeks post-intervention)

6. Change in physical activity: Intensity of Activity

   The investigators will collect data on physical activity as a surrogate measure of increase in energy. The ActiGraph wGT3X-BT® is a validated accelerometer used to measure physical activity outcomes, including percentage of time spent in sedentary, light, moderate, and vigorous physical activity. The ActiGraph wGT3X-BT will be worn on the wrist for 5 days to yield three 24 hour data for a percentage of time spent in different intensity activity daily.

   Time frame: Baseline to Week 11 (4 weeks post-intervention)

Other outcomes

1. Commonly used strategies to manage fatigue

   The Energy Conservation Strategies Survey assesses which energy conservation strategies they have used in the past 6 weeks and how effective they perceive these strategies to be in managing their fatigue. The survey lists 14 strategies. Strategy effectiveness in managing fatigue is rated on a 10-point scale with 1 indicating not effective and 10 indicating very effective.

   Time frame: Baseline to 4-weeks after intervention completion

Individual participant data

Plan to share: No