Back to resultsPurpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Purpose Project
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Between 25 and 74 years of age
- Completed chemotherapy and/or radiation treatment for Stage 1, 2, or 3 breast cancer up to 5 years prior to study enrollment
- English speaking
- Graduated from high school
- Able to see, hear, speak (with or without assistive devices)
- Able to provide own transportation to sessions
- 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:
- Stage 4 breast cancer or any other stage 4 cancer
- Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)
- History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning
- Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.
Sites / Locations
- Abbott Northwestern Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Purpose Project Group
Arm Description
Group receiving Purpose Project intervention.
Outcomes
Primary Outcome Measures
Change in psychological well-being
Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, & Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.
Secondary Outcome Measures
Recruitment
Number of prospective participants approached by clinicians and number of self-referred prospective participants who contact PI or Study Coordinator with inquiries about the study
Time of pre-testing session
Actual length (in minutes) of pre-testing session.
Time of testing session
Actual length (in minutes) of testing session.
Time of post-testing session
Actual length (in minutes) of testing session.
Homework completion
Whether or not homework was attempted
Intervention fidelity
Which key intervention elements were provided during a given session
Change in Meaning in life
Meaning in Life Questionnaire (Steger et al., 2006): A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).
Change in Satisfaction with Participation in Discretionary Social Activities
Satisfaction with Participation in Discretionary Social Activities (Hahn et al., 2010): Self-report questionnaires in which participants rated their level of satisfaction (1-5 scale) with social roles (14 items) and discretionary activities (12 items).
Engagement in Meaningful Activities
Engagement in Meaningful Activities Survey (Eakman, 2010):A 12-item self-report questionnaire designed to measure the extent to which a person experiences meaningfulness in his/her daily life activities.
Purpose Status and Expectations
A 2-question self-report developed by the study team to better understand what participants' hope to gain during the study and perceived changes.
Participant Experience of Purpose Project
Participant experience of purpose project as measured by self-report questionnaire and post-intervention interview.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03233334
Brief Title
Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)
Official Title
Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allina Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Purpose Project Group
Arm Type
Experimental
Arm Description
Group receiving Purpose Project intervention.
Intervention Type
Behavioral
Intervention Name(s)
Purpose Project
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in psychological well-being
Description
Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, & Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.
Time Frame
Will be administered at Week 0 (pre-testing) and at Week 12 (session 8).
Secondary Outcome Measure Information:
Title
Recruitment
Description
Number of prospective participants approached by clinicians and number of self-referred prospective participants who contact PI or Study Coordinator with inquiries about the study
Time Frame
Up to 1 month after IRB approval
Title
Time of pre-testing session
Description
Actual length (in minutes) of pre-testing session.
Time Frame
Duration of pre-testing session (approximately 2 hours) at week 0 to week 1
Title
Time of testing session
Description
Actual length (in minutes) of testing session.
Time Frame
Each week from week 2 through week 8, approximately 2.5 hours at each session
Title
Time of post-testing session
Description
Actual length (in minutes) of testing session.
Time Frame
Duration of session 8 (at week 12), approximately 2 hours
Title
Homework completion
Description
Whether or not homework was attempted
Time Frame
Each week from week 2 through week 8
Title
Intervention fidelity
Description
Which key intervention elements were provided during a given session
Time Frame
Each week from week 2 through week 8
Title
Change in Meaning in life
Description
Meaning in Life Questionnaire (Steger et al., 2006): A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).
Time Frame
At week 0 and at week 12
Title
Change in Satisfaction with Participation in Discretionary Social Activities
Description
Satisfaction with Participation in Discretionary Social Activities (Hahn et al., 2010): Self-report questionnaires in which participants rated their level of satisfaction (1-5 scale) with social roles (14 items) and discretionary activities (12 items).
Time Frame
At week 0 and at week 12
Title
Engagement in Meaningful Activities
Description
Engagement in Meaningful Activities Survey (Eakman, 2010):A 12-item self-report questionnaire designed to measure the extent to which a person experiences meaningfulness in his/her daily life activities.
Time Frame
At week 0 and at week 12
Title
Purpose Status and Expectations
Description
A 2-question self-report developed by the study team to better understand what participants' hope to gain during the study and perceived changes.
Time Frame
At Week 12
Title
Participant Experience of Purpose Project
Description
Participant experience of purpose project as measured by self-report questionnaire and post-intervention interview.
Time Frame
At week 12 and at week 14-20
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 25 and 74 years of age
Completed chemotherapy and/or radiation treatment for Stage 1, 2, or 3 breast cancer up to 5 years prior to study enrollment
English speaking
Graduated from high school
Able to see, hear, speak (with or without assistive devices)
Able to provide own transportation to sessions
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:
Stage 4 breast cancer or any other stage 4 cancer
Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)
History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning
Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Radomski, PhD, OTR/L
Organizational Affiliation
Allina Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)
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