Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06331403
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-11
Brief Title:
Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Open Pilot Trial of a Novel Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of this protocol is to conduct an open pilot to collect initial quantitative and qualitative feedback on the intervention that the investigators are developing To do so the investigators will deliver a newly-developed intervention to up to 2 consecutive groups of female colorectal and anal cancer survivors n up to 10 per group total N up to 20 Participants will provide feedback regarding intervention acceptability feasibility and perceived benefit
To inform plans for ongoing program refinement the investigators will elicit specific feedback about study assessment tools recruitment procedures and group factors Given the early-stage open pilot nature of this protocol the investigators will not set strict criteria to establish feasibility and acceptability but will rather interpret each of these outcomes holistically Qualitative feedback collected in post-intervention exit interviews will also support understanding of feasibility and acceptability
As a secondary aim the investigators will explore the preliminary effects of the intervention on psychosocial measures of satisfaction with sexuality and impact of functional limitations coping abilities acceptance of body image changes loneliness and anticipated stigma As noted above the investigators will not set specific criteria to establish preliminary efficacy nor will they consider statistical significance as an indicator of the studys efficacy for these outcomes Instead the investigators will consider pre-post intervention effect sizes to consider the need for refinement of study proceduresmeasurement in a future larger trial
In future larger-scale work the investigators intend to conduct a larger randomized pilot trial to assess intervention acceptability feasibility as well as preliminary efficacy on essential outcomes related to sexual well-being
To inform plans for ongoing program refinement the investigators will elicit specific feedback about study assessment tools recruitment procedures and group factors Given the early-stage open pilot nature of this protocol the investigators will not set strict criteria to establish feasibility and acceptability but will rather interpret each of these outcomes holistically Qualitative feedback collected in post-intervention exit interviews will also support understanding of feasibility and acceptability
As a secondary aim the investigators will explore the preliminary effects of the intervention on psychosocial measures of satisfaction with sexuality and impact of functional limitations coping abilities acceptance of body image changes loneliness and anticipated stigma As noted above the investigators will not set specific criteria to establish preliminary efficacy nor will they consider statistical significance as an indicator of the studys efficacy for these outcomes Instead the investigators will consider pre-post intervention effect sizes to consider the need for refinement of study proceduresmeasurement in a future larger trial
In future larger-scale work the investigators intend to conduct a larger randomized pilot trial to assess intervention acceptability feasibility as well as preliminary efficacy on essential outcomes related to sexual well-being
Detailed Description:
This is an open pilot trial to gather initial data regarding feasibility acceptability and perceived impact of a 6-session mind-body group intervention that the investigators are developing to enhance sexual well-being among post-treatment female colorectal and anal cancer survivors
The investigators will enroll up to 10 women per group into up to 2 groups total N up to 20 The team will run groups consecutively so that any necessary changes from the first open pilot group may be incorporated and re-examined in the second
Participants will complete informed consent prior to initiation of study procedures To inform ongoing intervention refinement the investigators will ask participants to complete approximately 15-minute survey batteries via REDCap at baseline and after the 6-session program including assessments of intervention feasibility and acceptability as well as psychosocial outcomes Participants will also be invited to complete a brief qualitative exit interview with a member of the study team regarding perceived benefit of the intervention as well as and strengths and weaknesses of program content and delivery format to inform ongoing intervention refinement
The investigators will enroll up to 10 women per group into up to 2 groups total N up to 20 The team will run groups consecutively so that any necessary changes from the first open pilot group may be incorporated and re-examined in the second
Participants will complete informed consent prior to initiation of study procedures To inform ongoing intervention refinement the investigators will ask participants to complete approximately 15-minute survey batteries via REDCap at baseline and after the 6-session program including assessments of intervention feasibility and acceptability as well as psychosocial outcomes Participants will also be invited to complete a brief qualitative exit interview with a member of the study team regarding perceived benefit of the intervention as well as and strengths and weaknesses of program content and delivery format to inform ongoing intervention refinement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None