Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)

NCT ID: NCT03233334

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-01-31

Brief Summary

The Purpose Project intervention is an 8-session progressive structure that was developed based on theoretical and scientific evidence from psychology and occupational therapy. The goal of the intervention is to provide participants with information, tools, and support that help them move towards reclaiming a sense of self-grounded purpose in daily life. The study will use a convenience sample of women with breast cancer to evaluate the feasibility of the Purpose Project intervention in terms of demand/acceptability, implementation, and limited-efficacy testing. Findings will be used to inform a later study to evaluate the efficacy of the Purpose Project intervention.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Purpose Project Group

Group receiving Purpose Project intervention.

Group Type: EXPERIMENTAL

Purpose Project

Intervention Type: BEHAVIORAL

The purpose project intervention 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in life that helps them flourish.

Interventions

Purpose Project

The purpose project intervention 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in life that helps them flourish.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Between 25 and 74 years of age

2. Completed chemotherapy and/or radiation treatment for Stage 1, 2, or 3 breast cancer up to 5 years prior to study enrollment

3. English speaking

4. Graduated from high school

5. Able to see, hear, speak (with or without assistive devices)

6. Able to provide own transportation to sessions

7. Willing and able to commit to attend all 8 intervention sessions, 2 testing sessions, and the one-to-one interview that occurs after completing the 8 intervention sessions.

Exclusion Criteria

1. Stage 4 breast cancer or any other stage 4 cancer

2. Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)

3. History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning

4. Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Allina Health System

OTHER

Sponsor Role: lead

Responsible Party

Mary Radomski

Senior Scientific Advisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Radomski, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

Allina Health

Locations

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

CKMR-1702

Identifier Type: -

Identifier Source: org_study_id