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Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA)

Primary Purpose

Insomnia, Insomnia Due to Medical Condition, Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEP-YA with Coaching
STEP-YA without Coaching
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Insomnia Due to Medical Condition, Cancer

Eligibility Criteria

20 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

To be determined by patient self-report from eligibility screening with potential participants. (See Appendix A for eligibility screening materials). Participants must be screened for eligibility ≤2 weeks prior to study enrollment. Participants who are screened earlier must be rescreened within this period.

  • Age 20-39
  • History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior
  • No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned
  • Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
  • Able to read and write in English

Exclusion Criteria:

  • Survivors who report ever being diagnosed with Bipolar Disorder.
  • Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months.
  • Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period.
  • Survivors who report being diagnosed with sleep apnea who are not receiving recommended medical treatment for their sleep apnea (as assessed by screening questions, see Appendix A).
  • Survivors who report suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).
  • Survivors who report their usual bedtime does not fall between 5:00 pm and 5:00 am.
  • Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones, or employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery)
  • Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.
  • Prior participation in a research study which provided an educational or behavioral intervention for insomnia
  • Prior participation in a behavioral treatment or patient education program for insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children's Hospital.
  • Participation in behavioral or educational interventions for insomnia in the 2 years prior to enrollment. This includes in-person as well as synchronous and asynchronous online insomnia programs, but not independent use of books, workbooks or other written self-help materials addressing insomnia.

Sites / Locations

  • Dana-Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NON-COACHING CONDITION STEP-YA

COACHING CONDITION STEP-YA

Arm Description

Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.

Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.

Outcomes

Primary Outcome Measures

Insomnia Severity Change at 8 Weeks
The Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms will be used.

Secondary Outcome Measures

Profile of Mood States Change at 8 weeks
The Profile of Mood States - Short Form (POMS-SF), a 35-item measure of participant mood states that provides multiple scales including an overall Total Mood Disturbance (TMD) score will be used
Profile of Mood States Change at 4 weeks
The Profile of Mood States - Short Form (POMS-SF), a 35-item measure of participant mood states that provides multiple scales including an overall Total Mood Disturbance (TMD) score will be used
Insomnia Severity Change at 4 weeks
The Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms will be used.

Full Information

First Posted
April 28, 2022
Last Updated
February 28, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05358951
Brief Title
Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA)
Official Title
Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): An Online Educational Intervention for Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2022 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

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 of the study is to learn if a single online education session, with or without individualized coaching sessions, can help improve young adult cancer survivors' (YACS) sleep. The name of the study intervention is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).
Detailed Description
This study is a randomized controlled trial of young adult cancer survivors with clinically significant symptoms of insomnia to evaluate the cognitive-behavioral based Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA). All participants will take part in a single STEP-YA session, during which they will complete baseline measures prior to randomization and then receive the STEP-YA intervention. Participants will then be randomly assigned to receive the STEP-YA intervention either, 1) alone (non-coaching condition), or 2) with the addition of 2 remote coaching sessions (coaching condition). Participants will also complete follow-up measures 4 and 8 weeks post-baseline. It expected that about 74 people will take part in this study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Insomnia Due to Medical Condition, Cancer
Keywords
Insomnia, Insomnia Due to Medical Condition, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NON-COACHING CONDITION STEP-YA
Arm Type
Active Comparator
Arm Description
Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
Arm Title
COACHING CONDITION STEP-YA
Arm Type
Experimental
Arm Description
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
Intervention Type
Behavioral
Intervention Name(s)
STEP-YA with Coaching
Intervention Description
Online instruction on behavioral changes to improve sleep with 2 additional individually coached session
Intervention Type
Behavioral
Intervention Name(s)
STEP-YA without Coaching
Intervention Description
Online instruction on behavioral changes to improve sleep without additional individually coached session
Primary Outcome Measure Information:
Title
Insomnia Severity Change at 8 Weeks
Description
The Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms will be used.
Time Frame
Baseline to 8-weeks post-intervention session
Secondary Outcome Measure Information:
Title
Profile of Mood States Change at 8 weeks
Description
The Profile of Mood States - Short Form (POMS-SF), a 35-item measure of participant mood states that provides multiple scales including an overall Total Mood Disturbance (TMD) score will be used
Time Frame
Baseline to 8-weeks post-intervention session
Title
Profile of Mood States Change at 4 weeks
Description
The Profile of Mood States - Short Form (POMS-SF), a 35-item measure of participant mood states that provides multiple scales including an overall Total Mood Disturbance (TMD) score will be used
Time Frame
Baseline to 4-weeks post-intervention session
Title
Insomnia Severity Change at 4 weeks
Description
The Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms will be used.
Time Frame
Baseline to 4-weeks post-intervention session
Other Pre-specified Outcome Measures:
Title
Insomnia Severity at 16 weeks (optional)
Description
The Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms will be used.
Time Frame
16 weeks post-intervention session
Title
Initial Satisfaction with Intervention Session
Description
Study specific questionnaire assessing intervention acceptability, credibility and participant satisfaction
Time Frame
Up to 4 weeks post-intervention
Title
Satisfaction with Coaching Sessions
Description
Study specific questionnaire describing satisfaction with coaching sessions
Time Frame
Up to 4 weeks post-intervention
Title
Final satisfaction with the intervention
Description
Study specific questionnaire asking about participant satisfaction with the intervention
Time Frame
8 Weeks post-intervention session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be determined by patient self-report from eligibility screening with potential participants. (See Appendix A for eligibility screening materials). Participants must be screened for eligibility ≤2 weeks prior to study enrollment. Participants who are screened earlier must be rescreened within this period. Age 20-39 History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned Significant insomnia as evidenced by an Insomnia Severity Index score ≥12 Able to read and write in English Exclusion Criteria: Survivors who report ever being diagnosed with Bipolar Disorder. Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months. Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period. Survivors who report being diagnosed with sleep apnea who are not receiving recommended medical treatment for their sleep apnea (as assessed by screening questions, see Appendix A). Survivors who report suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A). Survivors who report their usual bedtime does not fall between 5:00 pm and 5:00 am. Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones, or employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery) Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently. Prior participation in a research study which provided an educational or behavioral intervention for insomnia Prior participation in a behavioral treatment or patient education program for insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children's Hospital. Participation in behavioral or educational interventions for insomnia in the 2 years prior to enrollment. This includes in-person as well as synchronous and asynchronous online insomnia programs, but not independent use of books, workbooks or other written self-help materials addressing insomnia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
STEP-YA Study Coordinator
Phone
617-582-8260
Email
step@dfci.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cheryl Medeiros-Nancarrow
Phone
617-632-5798
Email
cheryl_nancarrow@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Recklitis, PhD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher J Recklitis, PhD, MPH
Phone
617-632-3839
Email
Christopher_Recklitis@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Christopher J Recklitis, PhD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA)

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