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Completed

NCT Number: NCT03282214

A Self-Management Energy Conservation Program for Cancer-Related Fatigue

The purpose of this pilot study is to examine a 12-week self-management energy conservation program (ECAM)'s effects on fatigue, and secondarily on sleep, physical activity, anxiety and depression, self-efficacy, and beliefs about fatigue in a group of Thai women with breast cancer who are undergoing chemotherapy. We will also evaluate how well women like the intervention, how easy it is to use and whether women will do the activities.

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Key information

Conditions

Cancer-related Problem/Condition Breast Diseases Breast Neoplasms Cancer, Breast Fatigue Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Saraburi Hospital, Changwat Sara Buri, Thailand

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About this study

Cancer-related fatigue is a distressing and multidimensional symptom. Research in the US has explored the efficacy of energy conservation interventions for fatigue and related symptoms but no previous ECAM programs have been tested in Thailand.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Thai women are age 18 or older; are diagnosed with stage I-III breast cancer; are scheduled to receive at least four cycles of chemotherapy given in 21-day-intervals; report at least 4 out of 10 or higher on a fatigue scale in the past month; are able to read and write in Thai and can be contacted by telephone.

Exclusion criteria

  • Thai women have a history of severe psychiatric illness, or have other illnesses that could be responsible for the fatigue other than cancer such as iron deficiency anemia, multiple sclerosis, congestive heart failure, chronic fatigue syndrome or fibromyalgia. With regard to anemia, women must have a certain hemoglobin in the normal range at baseline. They also cannot have acute or chronic bone, joint, or muscular abnormalities that would increase the risk of falls and injury. Women scheduled to receive concurrent radiation therapy are not eligible.

Treatment and study plan

Self-management energy conservation

Behavioral

The experimental group will receive four sessions approximately every three weeks with the PI. These sessions will correspond to the cycles of chemotherapy they will receive, with the first two sessions being during cycle 1, and sessions 3 and 4 being during cycles 2 and 3 of chemotherapy, respectively. The women will be instructed on how to assess their activity patterns by making a list prioritizing their usual activities. The journal and priority list (a "to do" list) provide the basis for the second session. In this session, the participant will learn to create a plan for managing valued activities to minimize the amount of energy used, to report the fatigue experienced during and after an activity done in the journal and will learn strategies to manage fatigue and optimize activity. In the third session, the participant will evaluate and revise their individualized plan. In addition, the participant will be instructed to wear a pedometer to record objective physical activity.

Primary outcomes

  1. Cancer-related fatigue (CRF)

    Time frame: Change from baseline CRF scores at 12 weeks

    A 22-item scale, 0 to 10 numerical scaling, with four dimensions of fatigue will be used to measure CRF severity.

Secondary outcomes

  1. Acceptability

    Time frame: at 12 weeks

    Open-ended questions will be used to ask about the most positive and negative aspects of the intervention, what modules did they use the most, what were barriers to using the intervention, what would they like to see added or deleted in future modules, and any suggestions on how the program could be improved.

  2. Satisfaction

    Time frame: at 12 weeks

    Scaling questions about satisfaction with the intervention will be responded on a 5-point scale (1 = dissatisfied to 5 = completely satisfied).

  3. The General Sleep Disturbance (GSD)

    Time frame: Change from baseline GSD scores at 12 weeks

    A 21-item, eight-point Likert scale from 0 (never) to 7 (every day) will be used to measure subjective sleep disturbance.

  4. Physical Activity (subjective measure)

    Time frame: Change from baseline GSLTPAG scores at 12 weeks

    Godin Leisure-Time Physical Activity Questionnaire (GSLTPAQ): A 4-item self-administered questionnaire asking information about the number of times one engages in mild, moderate, and strenuous leisure-time physical activity bouts of at least 15 minutes duration in a week, and also asking how often participants typically engage in any regular activity until sweating or a racing heart on a scale of often, sometimes, never or rarely.

  5. Physical Activity (objective measure)

    Time frame: Changes from baseline steps per day at 12 weeks

    A pedometer will be used to assess how many steps are taken each day.

  6. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Change from baseline HADS scores at 12 weeks

    The HADS is a 14-item questionnaire

  7. Self-Efficacy for Managing Chronic Disease Scale (SEMCDS)

    Time frame: Change from baseline SEMCDS scores at 12 weeks

    This 6-item scale contain items will be used to measures self-reported current level of confidence to manage control the patient's symptoms, role function, emotional functioning, and communicating with physicians.

  8. Fatigue Belief Questions (FBQ)

    Time frame: Change from baseline FBQ scores at 12 weeks

    A 20-item, six-point Likert scale from 1 (strongly disagree) to 6 (strongly agree) will be used to measure the fatigue beliefs.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Ministry of Health, Thailand
  • National Institutes of Health (NIH)

Registry information

Official study title

A Self-Management Energy Conservation Program for Cancer-Related Fatigue in Thai Women With Breast Cancer Receiving Chemotherapy: A Pilot Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2017
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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