Participation Restrictions in Breast Cancer Survivors

December 18, 2014 updated by: Dartmouth-Hitchcock Medical Center

Participation Restrictions in Young-Middle Adult Rural Breast Cancer Survivors

This project will develop and preliminarily evaluate an intervention to assist young-middle adult rural breast cancer survivors to overcome functional impairments related to their cancer treatment. Younger breast cancer survivors (below age 60) have ongoing family, social and vocational responsibilities and recreational interests and are at increased risk of developing long-term difficulties performing these valued activities (participation restrictions). Rural cancer survivors are medically underserved and due to distance and geographic isolation face significant barriers to accessing traditional rehabilitation services. Alternative rehabilitation approaches are sorely needed for this population. Based on previous research with cancer and other medical populations a working draft of a treatment manual using a telephone-delivered Behavioral Activation and Problem Solving (BA/PS) intervention has been designed. Prior to testing the intervention in a randomized clinical trial, additional work must be completed. The specific aims of this study are to a. refine the BA/PS treatment manual, b. develop and apply treatment integrity measures for the BA/PS manual, c. assess participation restrictions and associated outcomes, d. preliminarily assess the immediate and maintenance effects of BA/PS, and e. examine mediators and moderators of BA/PS effects based on our "Self Regulation" model of functional recovery. 188 young-middle adult breast cancer survivors will be screened for participation restrictions following cancer treatment and 40 survivors with participation restrictions will receive BA/PS delivered by phone. BA/PS participants will be assessed for treatment effectiveness and interviewed regarding their experiences during treatment to provide information for refining the manual. The long-term objective of this line of research is to develop effective and feasible treatments for the medical and psychosocial consequences of cancer and its treatment in medically underserved cancer survivors (e.g., rural populations).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female breast cancer patient stages I-III.
  2. Age 18-59.
  3. Completion of definitive breast cancer treatment (i.e., subsequent to loco-regional surgical treatment and completion of adjuvant or neo-adjuvant chemotherapy with or without radiation) within the past 3-6 months.
  4. Screen positive for a moderate or worse level of participation restriction (Work and Social Adjustment Scale score > 10) within 6 months following cancer treatment.
  5. English speaking.
  6. Have a land-based phone or reliable cell phone reception.

Exclusion Criteria:

  1. Non-correctable hearing loss.
  2. Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
  3. Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder) or active substance abuse.
  4. Medical record documentation of a physical disorder with associated functional impairment (e.g., Parkinson's disease, stroke, congestive heart failure, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Telephone-delivered Behavioral Activation/Problem Solving (BA/PS) intervention
Behavioral: Behavioral activation/problem-solving (BA/PS)
Six weekly telephone sessions to train participant in BA/PS procedures

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: six weeks
  • of patients evaluated for enrollment / # of patients approached.
  • of patients meeting eligibility criteria / # of patients evaluated.
  • of patients enrolled / # of patients meeting eligibility criteria
  • of patients completing 6 weeks of BA/PS treatment.
  • of patients completing each study assessment point (T1, T2, T3, T4).
six weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional status
Time Frame: baseline, six weeks, 12 weeks, 18 weeks
The Medical Outcomes Short Form-36 (MOS SF-36) consists of eight scales (physical functioning, role limitations - physical, role limitations - emotional, vitality, well being, social functioning, bodily pain, and general health) and two standardized component summary scores (physical and mental). The physical and mental factors account for 80-85% of the variance in the scales. We will use the Physical Component Summary (PCS) Score as the primary outcome measure.
baseline, six weeks, 12 weeks, 18 weeks
Quality of life
Time Frame: baseline, six weeks, 12 weeks, 18 weeks
The Functional Assessment of Cancer Therapy-Breast Cancer + Arm Morbidity (FACT-B+4) is a 41-item self-report measure of health-related quality of life specifically designed for breast cancer patients.
baseline, six weeks, 12 weeks, 18 weeks
Affective symptoms
Time Frame: baseline, six weeks, 12 weeks, 18 weeks
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report measure of depressive and anxiety symptoms specifically designed for medical patients. The HADS contains only the cognitive symptoms of depression and anxiety, thus eliminating the somatic symptoms that are poor indicators of psychiatric distress in the medically ill.
baseline, six weeks, 12 weeks, 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dartmouth-Hitchcock Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark T Hegel, PhD, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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