Health TrialsbyHealthPanel

Optimizing Functional Recovery After Breast Cancer Treatment

ConditionBreast Neoplasms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMGH Institute of Health Professions

About this trial

The goal of this clinical trial is to determine the best way to promote participation in vocational, social, physical, and instrumental activities of daily living in people who have completed treatment for early stage breast cancer.

The main question it aims to answer is: Which of the intervention components, alone or in combination, most effectively promote participation in vocational, social, physical, and instrumental activities of daily living?

Participants will be asked to try one of 8 combination of three intervention components that have been shown to promote activity participation: (1) priority elicitation, (2) education, and (3) guided application involving goal setting, problem-solving and action planning.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age of 18 years or older,

Diagnosed with Stage 1-3 breast cancer and within one year of completion of locoregional treatment and/or adjuvant therapy with curative intent and absence of disease recurrence,

Experiencing reduced participation (i.e., a score of > 10 on the Work and Social Adjustment Scale).

Disqualifiers

Non-English speaking.

Non-correctable hearing loss.

Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.

History of severe mental illness (i.e., schizophrenia, bipolar disorder), current major depressive disorder, active suicidal ideation, or active substance misuse documented within the medical record.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Individually tailored education and guided application to promote activity participation

    Behavioral

    This condition has high levels of the three components: (1) priority-elicitation and session tailoring; (2) cancer survivorship education; and (3) guided application involving goal setting, problem-solving, and action planning.

  • Individually tailored guided application

    Behavioral

    This condition contains high levels of priority elicitation and guided application.

  • Individually tailored education

    Behavioral

    This condition contains how levels of the components of priority elicitation and education

  • Priority elicitation

    Behavioral

    This condition contains the high level of the priority elicitation component

  • Static education and guided application

    Behavioral

    This condition has high levels of the education and guided application components

  • Static guided application

    Behavioral

    This condition contains high level of the guided application component

  • Static education

    Behavioral

    This condition contains the high level of the education component

  • Information

    Behavioral

    This condition contains the low levels of the three components

Treatment groups

352 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Priority elicitation, education, and guided applicationExperimental treatment 1 intervention
Group B: Priority elicitation and guided applicationExperimental treatment 1 intervention
Group C: Priority elicitation and educationExperimental treatment 1 intervention
Group D: Priority elicitationExperimental treatment 1 intervention
Group E: Education and guided applicationExperimental treatment 1 intervention
Group F: Guided applicationExperimental treatment 1 intervention
Group G: EducationExperimental treatment 1 intervention
Group H: InformationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Participation satisfaction: PROMIS Satisfaction with Social Roles and Activities Short Form 8a

Scores range from 8 to 40, with higher values representing greater satisfaction with ability to participate in social roles and activities.

Time frame
Baseline to week 20

Secondary outcomes

1

Participation ability: Ability to Participate in Social Roles and Activities Short Form 8a

Scores range from 8 to 40, with lower values representing greater difficulty participating in social roles and activities

Time frame
Baseline to 20 weeks
2

Valuing Questionnaire: Engagement in valued activities

Two subscales of five items each. Progress subscale ranges from 0 to 30 with high scores reflecting better concordance between values and actions. Obstruction subscale ranges from 0 to 30 with high scores reflecting more interference between values and actions.

Time frame
Baseline to 20 weeks
3

Self-efficacy for health management: Self-Efficacy for Managing Chronic Disease Scale

Scores range from 6 to 60 with higher scores indicating higher self-efficacy

Time frame
Baseline to 20 weeks
4

Adaptive coping: Brief COPE subscales

Three subscales of the Brief COPE: planning, active coping, and positive reframing. Scores on each subscale are calculated as the sum of two items, thus possible scores range from 0 to 6, with higher values representing greater use of active coping strategies.

Time frame
Baseline to 20 weeks

Other outcomes

1

Acceptability of intervention components

Open-ended questions regarding acceptability and utility of components received

Time frame
8 weeks post-baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MGH Institute of Health Professions

Lead sponsor

University of Alabama at Birmingham

Collaborator

University of South Alabama

Collaborator

Dartmouth-Hitchcock Medical Center

Collaborator

Source ClinicalTrials.gov

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