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INSPIRE: Internet and Social-media Program With Information and Resources for Long-Term Cancer Survivors Who Underwent Stem Cell Transplant (INSPIRE)

Primary Purpose

Cancer Survivor, Depression, Hematopoietic and Lymphoid Cell Neoplasm

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Internet-Based Intervention

Medical Chart Review

Quality-of-Life Assessment

Questionnaire Administration

About this trial

This is an interventional supportive care trial for Cancer Survivor focused on measuring stem cell transplant, cancer survivors, internet, social media, distress, health care adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Received a transplant at a consortium center for a hematologic malignancy or myelodysplasia
Currently 2-10 years after first HCT

Exclusion Criteria:

Does not have internet and email access; note that survivors otherwise eligible, but excluded from full study participation because of this exclusion, will be asked to fill out a mailed copy of the baseline assessment for use in secondary aims analyses; they will be sent an information form and a copy of the tailored 'My Health Action Plan' health care guideline for transplant survivors also provided to randomized participants
English insufficient to complete baseline patient-reported outcomes (PRO) assessments
Has received treatment for a recurrent or 2nd cancer that required > surgical excision in the past 2 years or did not have a hematologic malignancy or myelodysplasia diagnosis or did not receive a first transplant between 2-10 years before approach for the study; (these participants will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment)
Scores 20 or above on the patient health questionnaire (PHQ)-8 depression measure (indicating severe depression); these participants will be contacted by a study psychologist to evaluate and provide resources to address their needs (2% of enrollees in our previous study); they will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment
Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
Does not complete baseline PRO assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
Has medical or health issues prohibiting computer use (e.g., vision-impaired, cognitively impaired, illness or accident impairing computer function)

Sites / Locations

Moffitt Cancer Center
Wayne State University/Karmanos Cancer Institute
University of Nebraska Medical Center
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
University of Pennsylvania/Abramson Cancer Center
Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm I (INSPIRE internet full program access)

Arm II (delayed program access control)

Arm Description

Participants receive full access to the INSPIRE internet site comprising an individually tailored program with a greeting home page with links to each target area, a 'My Health Action Plan' health care guideline for transplant survivors, self-care tips and tool pages for each complication and major issues for HCT survivors, a section for each complication (mood, energy, heart health, strengthening bones, second cancers), resource pages, opportunities to send secure messages with questions or comments on any topic, opportunities to request additional assistance or information, mobile texting options, and social media links (Twitter/Facebook/Pinterest) maintained and monitored by the Social Media Specialist.

Participants receive annotated website links to existing transplant and cancer survivor sites, followed by delayed access to the INSPIRE internet program after 1 year.

Outcomes

Primary Outcome Measures

Cancer and treatment distress (CTXD) score as reported on the PCA using binary outcomes

PHQ-8 depression score as reported on the PCA, using binary outcomes

Proportion of adherence to recommended survivorship preventive care and barriers to PCA

Secondary Outcome Measures

Health behaviors

Composite measure of health behaviors, including tobacco use, alcohol use, physical activity, use of sunscreen, food intake, body mass index, and sleep.

Physical function, as assessed by the Patient Reported Outcomes Measurement Information System scale

Total minutes per week of moderate to vigorous intensity exercise as assessed by the Godin Leisure Time Exercise Questionnaire

This measure is a measure of leisure time physical activity.

Full Information

NCT ID

NCT01602211

First Posted

May 15, 2012

Last Updated

July 29, 2020

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01602211

Brief Title

INSPIRE: Internet and Social-media Program With Information and Resources for Long-Term Cancer Survivors Who Underwent Stem Cell Transplant

Acronym

INSPIRE

Official Title

INSPIRE for Survivorship After Transplant: A Multicenter Randomized Controlled Trial of an Internet and Social-Media Program for Long-Term Hematopoietic Cell Transplantation Survivors

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

May 14, 2013 (Actual)

Primary Completion Date

November 28, 2016 (Actual)

Study Completion Date

November 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This randomized clinical trial studies an internet and social-media program for improving quality of life in long-term survivors who underwent stem cell transplant. In this study, researchers want to compare a survivorship internet program to the standard treatment of currently available internet sites for transplant survivors to learn which works better for people who have received bone marrow or blood stem cell transplants. A survivorship-focused internet program may improve mood, stress, and preventive health care, and provide useful health resources for transplant survivors. It is not yet known whether currently available internet sites are more effective than a survivorship-focused internet program in improving quality of life in cancer survivors.

Detailed Description

PRIMARY OBJECTIVES: I. Determine whether 2-10 year hematopoietic cell transplant (HCT) survivors with elevated depression or cancer-related distress who are randomized to receive access to a tailored internet-based program report reduced depression and distress when compared with control group survivors who receive access to an internet site with links to transplant and cancer-specific online resources and delayed access to the internet site (active control). II. Determine whether survivors with low survivorship preventive care adherence (PCA) who are randomized to receive access to the tailored internet-based program, including a survivorship preventive care plan, report increased PCA when compared with the active control group survivors. SECONDARY OBJECTIVES: I. Secondary outcomes will include process measures of internet study reach and utilization, as well as physical function, physical activity level, and knowledge of survivorship needs. Further analyses will identify risk factors for disparities in survivorship preventive care adherence in HCT survivors. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Participants receive full access to the INSPIRE internet site comprising an individually tailored program with a greeting home page with links to each target area, a 'My Health Action Plan' health care guideline for transplant survivors, self-care tips and tool pages for each complication and major issues for HCT survivors, a section for each complication (mood, energy, heart health, strengthening bones, second cancers), resource pages, opportunities to send secure messages with questions or comments on any topic, opportunities to request additional assistance or information, mobile texting options, and social media links (Twitter/Facebook/Pinterest) maintained and monitored by the Social Media Specialist. ARM II: Participants receive annotated website links to existing transplant and cancer survivor sites, followed by delayed access to the INSPIRE internet program after 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer Survivor, Depression, Hematopoietic and Lymphoid Cell Neoplasm, Myelodysplastic Syndrome

Keywords

stem cell transplant, cancer survivors, internet, social media, distress, health care adherence

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I (INSPIRE internet full program access)

Arm Type

Experimental

Arm Description

Arm Title

Arm II (delayed program access control)

Arm Type

Experimental

Arm Description

Participants receive annotated website links to existing transplant and cancer survivor sites, followed by delayed access to the INSPIRE internet program after 1 year.

Intervention Type

Other

Intervention Name(s)

Internet-Based Intervention

Intervention Description

Receive full access to INSPIRE

Intervention Type

Other

Intervention Name(s)

Internet-Based Intervention

Intervention Description

Receive access to an annotated list of existing resources for transplant and cancer survivors and delayed access to INSPIRE site

Intervention Type

Other

Intervention Name(s)

Medical Chart Review

Other Intervention Name(s)

Chart Review

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Cancer and treatment distress (CTXD) score as reported on the PCA using binary outcomes

Time Frame

Up to 12 months

Title

PHQ-8 depression score as reported on the PCA, using binary outcomes

Time Frame

Up to 12 months

Title

Proportion of adherence to recommended survivorship preventive care and barriers to PCA

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

Health behaviors

Description

Composite measure of health behaviors, including tobacco use, alcohol use, physical activity, use of sunscreen, food intake, body mass index, and sleep.

Time Frame

Up to 12 months

Title

Physical function, as assessed by the Patient Reported Outcomes Measurement Information System scale

Time Frame

Up to 12 months

Title

Total minutes per week of moderate to vigorous intensity exercise as assessed by the Godin Leisure Time Exercise Questionnaire

Description

This measure is a measure of leisure time physical activity.

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Received a transplant at a consortium center for a hematologic malignancy or myelodysplasia Currently 2-10 years after first HCT Exclusion Criteria: Does not have internet and email access; note that survivors otherwise eligible, but excluded from full study participation because of this exclusion, will be asked to fill out a mailed copy of the baseline assessment for use in secondary aims analyses; they will be sent an information form and a copy of the tailored 'My Health Action Plan' health care guideline for transplant survivors also provided to randomized participants English insufficient to complete baseline patient-reported outcomes (PRO) assessments Has received treatment for a recurrent or 2nd cancer that required > surgical excision in the past 2 years or did not have a hematologic malignancy or myelodysplasia diagnosis or did not receive a first transplant between 2-10 years before approach for the study; (these participants will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment) Scores 20 or above on the patient health questionnaire (PHQ)-8 depression measure (indicating severe depression); these participants will be contacted by a study psychologist to evaluate and provide resources to address their needs (2% of enrollees in our previous study); they will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility) Does not complete baseline PRO assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria Has medical or health issues prohibiting computer use (e.g., vision-impaired, cognitively impaired, illness or accident impairing computer function)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Syrjala

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Wayne State University/Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

University of Pennsylvania/Abramson Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35662590

Citation

Farhadfar N, Weaver MT, Al-Mansour Z, Yi JC, Jim HSL, Loren AW, Majhail NS, Whalen V, Uberti J, Wingard JR, Lynch Kelly D, Syrjala KL. Self-Efficacy for Symptom Management in Long-Term Adult Hematopoietic Stem Cell Survivors. Transplant Cell Ther. 2022 Sep;28(9):606.e1-606.e8. doi: 10.1016/j.jtct.2022.05.035. Epub 2022 May 31.

Results Reference

derived

PubMed Identifier

32781287

Citation

Banerjee R, Yi JC, Majhail NS, Jim HSL, Uberti J, Whalen V, Loren AW, Syrjala KL. Driving Distance and Patient-Reported Outcomes in Hematopoietic Cell Transplantation Survivors. Biol Blood Marrow Transplant. 2020 Nov;26(11):2132-2138. doi: 10.1016/j.bbmt.2020.08.002. Epub 2020 Aug 8.

Results Reference

derived

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INSPIRE: Internet and Social-media Program With Information and Resources for Long-Term Cancer Survivors Who Underwent Stem Cell Transplant

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