The purpose of this study is to test whether four different supportive care programs can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) alongwith endocrine therapy with or without a PI3K or AKT inhibitor.
Women
Able to provide written informed consent
Able to speak, read, and understand English or Spanish
Postmenopausal (including concurrent use of ovarian suppression)
Unable to provide consent
Unable to read or understand English or Spanish
Dependent on supplemental oxygen
Unstable cardiac disease
Factorial
Prolonged Overnight Fasting
BehavioralParticipants will undergo a 12-week program of prolonged overnight fasting (POF) during which they will abstain from consuming food or drink after 8pm, and wait 12 to 14 hours before resuming eating the next day. Participants will fast overnight for six nights each week, with one night off, and log their fasting start and stop times and timing of food intake daily via text messaging, or via study-provided app accessible by web browser or smart phone, or via paper journal returned by mail at the end of each month. Participants will also complete one weekly session with a health coach to review their fasting log and any barriers to and/or facilitators of meeting the POF goals. Sessions may be delivered in-person, by telephone, or by video call based on participant preference. Sessions will last 15 to 30 minutes each, for a total of 12 sessions. Participants will be provided with a notebook with information and support to encourage meeting the POF goals.
Moderate-Intensity Exercise
BehavioralParticipants will undergo a 12-week program consisting of three weekly sessions of moderate-to-vigorous aerobic and resistance exercises, under the supervision of a health coach. Sessions may be delivered either in-person or virtually via telehealth. Sessions will be tailored to the individual participant based on fitness level and symptoms at study entry, and limited to daylight hours as much as possible. Each session will last 30 to 50 minutes, as tolerated by the participant, for a total of 36 sessions. Participants will receive a Fitbit device to track their activity, and to provide heart rate monitoring during each session. Participants without access to wi-fi will be loaned cellular-enabled tablets to allow them to participate in telehealth sessions. Participants will also receive a notebook with information and support to encourage exercise.
General Health Education Sessions
BehavioralParticipants will receive a general health education resource manual at study entry, followed by six bi-weekly sessions with a health coach to review the information. Six topics, one topic for each session, will be selected based on topics of potential interest to a population living with advanced breast cancer, focusing on general nutrition, healthy lifestyle, and quality of life, with no discussion of prolonged overnight fasting or exercise. Each session, administered via telephone or video call, will last about 15 to 30 minutes, and have a specific topic and call script for the health coach to follow to minimize any intervention drift and/or contamination. Participants will receive a Fitbit activity monitoring device and additional study materials at the end of their participation in the study.
Change in Cancer-Related Fatigue as Measured by EORTC QLQ-C30 Scores
Change in self-reported cancer-related fatigue as measured by participant scores on the European Organisation For Research And Treatment Of Cancer (EORTC) core quality of life questionnaire (QLQ) (EORTC QLQ-C30). The EORTC QLQ-C30 is a self-administered, 30-item questionnaire used to measure cancer patients' health-related quality of life. The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). For the raw score, less points are considered to have a better outcome. For the questions 29 and 30, the EORTC-QLQ-30 uses a 7-points scale. The scale scores from 1 to 7: 1 ("Very poor") to 7 ("Excellent"). More points are considered to have a better outcome.
Change in Sleep Quality as Measured by Pittsburgh Sleep Quality Index (PSQI) Scores
Change in sleep quality among participants across study arms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-administered questionnaire for evaluating subjective sleep quality. PSQI global scores range from 0 to 21, with higher scores indicating worse sleep quality.
Change in Incidence of Toxicity as Measured by PRO-CTCAE Scores
Change in incidence of toxicity among study participants across all study arms as measured by scores on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. The PRO-CTCAE was developed by the National Cancer Institute (NCI) to assess symptomatic adverse events (AEs) in adult patients receiving cancer therapy. The PRO-CTCAE is a self-administered questionnaire. The investigators will measure incidence of mouth/throat sores, taste changes, decreased appetite, nausea, vomiting, heartburn, constipation, diarrhea, abdominal pain, shortness of breath, neuropathy, concentration, memory, pain, insomnia, hot flashes, joint pain, and fatigue.
Change in Levels of Psychological Distress as Measured by Patient Health Questionnaire (PHQ-4) Scores
Change in patient-reported outcomes among participants across study arms as measured by scores on the Patient Health Questionnaire (PHQ-4). The PHQ-4 is a self-administered, 4-item valid screening instrument for detecting psychological distress due to anxiety and/or depression in participants. Scores range from 0 to 12, with higher scores indicating greater psychological distress.
Change in Quality of Life as Measured by EORTC QLQ-C30 Scores
Change in physical function and quality of life among study participants across all study arms will be measured by scores on the European Organisation For Research And Treatment Of Cancer (EORTC) core quality of life questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is a self-administered, 30-item questionnaire used to measure cancer patients' health-related quality of life. The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). For the raw score, less points are considered to have a better outcome. For the questions 29 and 30, the EORTC-QLQ-30 uses a 7-points scale. The scale scores from 1 to 7: 1 ("Very poor") to 7 ("Excellent"). More points are considered to have a better outcome.
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University of Miami
Lead sponsor
National Cancer Institute (NCI)
Collaborator
