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REJOIN Trial for Older Breast Cancer Survivors (REJOIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03955627
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Shirley Bluethmann, Milton S. Hershey Medical Center

Brief Summary:
The purpose of this pilot intervention study is to test the effectiveness of a self-management approach (combining education- and exercise-based strategies) for improving arthralgia (joint pain) associated with Aromatase Inhibitors (AI) in older breast cancer survivors. Survivors will be recruited from local cancer clinics prior to the completion of primary cancer treatment, as arthralgia can occur soon after initiating AI medication. Participants will be randomized to one of two groups: an enhanced standard care group (AI prescription plus information) or a treatment group (educational classes plus group exercise sessions). Older survivors (≥65 years) will be targeted because they are at increased risk of medication complications which may impede adherence. For the baseline assessment, a cancer-specific geriatric assessment will be conducted and a blood sample will be collected to interpret the effects of the self-management study in the context of geriatric experiences. Additionally, there will be an assessment of knowledge, PA habits, and AI-related joint pain and AI adherence. These will be measured again at 4, 6 and at follow up at 12 months.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Behavioral: Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN) Not Applicable

Detailed Description:

To improve AIA and AI Adherence in older survivors, it will: first, adapt an evidence-based intervention (AIM 1) and then; test the adapted intervention with breast cancer survivors ≥65 years. The Investigators will educate survivors about possible AI-related side effects and teach survivors ways to use PA to self-manage AIA (AIM 2), and support adherence to hormonal therapy recommendations (AIM 3). Given evidence that survivors experience AIA soon after initiating hormonal therapy, potentially eligible participants would be identified early in the treatment process. By identifying potential participants after diagnosis or during active treatment, survivors would have a minimal delay in beginning the exercise intervention after initiating hormonal therapy (i.e. AIs). All participants will have completed surgery, radiation and/or chemotherapy, which is consistent with current ASCO guidelines for AI use.

Two groups will be randomized to either an information-only group (enhanced standard care) or an education plus exercise group (treatment). At the initial clinical visit during the intervention, participants in both groups will receive printed information along with their AI medication prescription. The treatment group will subsequently receive a one-on-one exercise consultation with a certified exercise trainer (e.g ACSM or similar), followed by a modified version of the Fit & Strong! program, which includes bi-weekly supervised exercise (60 minutes) and educational sessions (30 minutes).

The exercise sessions will include light weights or resistance bands plus low-impact aerobic exercise, in which movements will be explained, demonstrated and modified based on the needs of participants. The exercise protocol will be reviewed and revised based on recommendations from clinical advisers. Educational materials will provide information about the purpose of AI medications (e.g., to reduce cancer recurrence) in layperson language and basic information about potential side effects. As part of in-person sessions, participants will develop a plan to continue exercise at home. Participants can do an activity of their choice (e.g., walking) and use resistance bands which will be provided for the at-home program which will begin after 8 weeks and will include follow up phone calls to assess progress and reinforce the program. Educational sessions will be modified to reflect relevant content and advice for older survivors beginning AIs. Assessments will be taken at 4 and 6 months, with follow up at 12 months.

For convenience of participants, sessions will take place on the Hershey Medical Campus.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Pilot. Enhanced Standard Care v. Treatment (education plus exercise).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Masked parties will not be told the arm to which the participant is assigned. Patient study records will indicate if they are in the study, but not the arm assignment. All participants will receive standard information about AI use and participate in four assessments.
Primary Purpose: Supportive Care
Official Title: Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study
Estimated Study Start Date : April 28, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Enhanced Standard Care
Participants will receive standard care, plus a brochure about hormonal therapy use.
Experimental: Treatment (Education plus Exercise)
Participants will receive the same materials as the standard care group, plus participate in group exercise and group discussion sessions.
Behavioral: Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN)
Self-management program which includes supervised exercise sessions in groups and group discussions for 8 weeks, following by an 8-week home-based version of the same program.
Other Name: REJOIN




Primary Outcome Measures :
  1. Brief Pain Inventory [ Time Frame: Change in pain experience from baseline at 6 months ]
    The Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI-sf is a modification of the Brief Pain Inventory - Long Form, which includes additional questions on demographics (date of birth, marital status, education, employment), pain history, aggravating and easing factors, treatment and medication, pain quality, and response to treatment.

  2. AI Medication Adherence [ Time Frame: Single measure (percent taken based on what was prescribed over the last 30 days) ]
    Medication Possession Ratio (MPR). Percent of days medication taken as prescribed, as self-reported by patient and verified with prescription refill records.


Secondary Outcome Measures :
  1. Modified Cancer and Aging Research Group (CARG) plus National Health and Nutrition Examination Survey (NHANES) and Patient-Reported Outcomes Measurement Information System (PROMIS) Geriatric Assessment Study Patient Questionnaire [ Time Frame: Single Measure (repeated at 4, 6 and 12 months) ]
    Aggregated assessment of self-reported information about demographic data, daily activities, nutritional status, medication use and health behaviors.

  2. Toronto Informational Needs Questionnaire -- Breast Cancer [ Time Frame: Single Measure (repeated at 4, 6 and 12 months) ]
    Self-report questionnaire about knowledge of breast cancer, its treatment and its side effects. Responses to questions about informational needs are reported using a Likert Scale -- 1 is "not important" to 5 "extremely important." Higher score indicate greater informational needs. Individual subscales may be calculated using percentages.

  3. The Exercise Self-efficacy Scale [ Time Frame: Single Measure (Repeated at 4, 6 and 12 months) ]
    The Exercise Self-Efficacy Scale assesses an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future. For each of 8 items, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must be biologically female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female, aged ≥ 65 years at the start of study
  2. Planning to initiate AIs
  3. Diagnosed stages I-III Breast Cancer
  4. ER+ tumor (at least 5% of cells)
  5. Completed surgery, radiation and/or chemotherapy
  6. Independent ambulatory (verified by treating clinician/staff)
  7. Physician approval to start an exercise program
  8. Currently sedentary (>60 min. of physical activity per week)
  9. Able to complete surveys and forms/ understand English
  10. Agree to random assignment to exercise or control group
  11. Can commit to 8 weeks, bi-weekly sessions in person ( if selected for treatment group)
  12. Minimum cognitive impairment (verified by cognitive screening questions administered by phone or in-person interview)

Exclusion Criteria:

  1. Already taking AIs (may participate if 4 weeks or less after initiating)
  2. Presence of metastatic cancer or concurrent malignancy requiring treatment
  3. Recent history (past 6 months) of stroke/ MI, atrial fibrillation or class 3, 4 heart failure
  4. Recent joint surgery or conditions limiting PA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955627


Contacts
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Contact: Erica Schleicher, MS 717-531-0003 ext x323324 eschleicher1@phs.psu.edu
Contact: Eileen Flores, MPH 717-531-0003 eflores@phs.psu.edu

Locations
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United States, Pennsylvania
Penn State Cancer Institute Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Erica Schleicher, MS    717-531-0003    eschleicher1@phs.psu.edu   
Principal Investigator: Shirley M Bluethmann, PhD, MPH         
Sponsors and Collaborators
Milton S. Hershey Medical Center
American Cancer Society, Inc.
Investigators
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Principal Investigator: Shirley M. Bluethmann, PhD, MPH Milton S. Hershey Medical Center
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Responsible Party: Shirley Bluethmann, Assistant Professor, Department of Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03955627    
Other Study ID Numbers: STUDY00010776
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will share deidentified data only, if requested.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shirley Bluethmann, Milton S. Hershey Medical Center:
Cancer Treatment Symptoms, Symptom Management
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases