Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633926
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Integrative Approaches for Cancer Survivorship IACS3
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integrative Approaches for Cancer Survivorship A Multi-Site Feasibility and Acceptability Study Aim 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial is a two-arm pilot randomized controlled trial for non-metastatic breast cancer survivors to determine the feasibility acceptability and fidelity of two integrative health approaches and study design in a multi-site setting Participants n104 will be randomized to either the Ayurveda Intervention AVI or Facing Forward Health Education Intervention FFHEI Integrative health combines biomedical and complementary approaches together in a coordinated way AVI a multi-modal intervention includes nutritional education lifestyle practices yoga and therapeutic touch called marma to help the body and mind feel balanced FFHEI provides health education using self-directed online content and interactive videos based on the latest science in cancer survivorship This study does not intend to conduct tests of efficacy and is focused on feasibility outcomes
Detailed Description:
PRIMARY OBJECTIVES
I Determine feasibility and acceptability of this design in a multi-site setting
SECONDARY OBJECTIVES
I Evaluate Quality of Life QOL
II Evaluate Cancer Associated Symptoms
OUTLINE Participants are randomized in a 11 ratio to 1 of 2 arms
ARM I Participants receive usual care on study Participants also receive nutrition education lifestyle recommendations and participate in yoga as well as marma therapeutic touch during one-on-one AVI visits over 1-2 hours for up to 14 visits over 6 months After 6 months participants may also complete a videoconference visit over 30 minutes once monthly for 6 months
ARM II Participants receive usual care on study Participants also access self-directed online HEI sessions over 1 hour each for up to 15 sessions over 6 months
I Determine feasibility and acceptability of this design in a multi-site setting
SECONDARY OBJECTIVES
I Evaluate Quality of Life QOL
II Evaluate Cancer Associated Symptoms
OUTLINE Participants are randomized in a 11 ratio to 1 of 2 arms
ARM I Participants receive usual care on study Participants also receive nutrition education lifestyle recommendations and participate in yoga as well as marma therapeutic touch during one-on-one AVI visits over 1-2 hours for up to 14 visits over 6 months After 6 months participants may also complete a videoconference visit over 30 minutes once monthly for 6 months
ARM II Participants receive usual care on study Participants also access self-directed online HEI sessions over 1 hour each for up to 15 sessions over 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None