Cancer SurvivorPhase 3INSPIRENCT01602211
INSPIRE: Internet and Social-media Program With Information and Resources for Long-Term Cancer Survivors Who Underwent Stem Cell Transplant
A Phase 3 study testing Internet-Based Intervention, Medical Chart Review and Quality-of-Life Assessment in people with Cancer Survivor and Depression, run by Fred Hutchinson Cancer Center at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivor, Depression, Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Internet-Based Intervention, Medical Chart Review and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 May 2013to 28 Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received a transplant at a consortium center for a hematologic malignancy or myelodysplasia
- Currently 2-10 years after first HCT
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Cancer Survivor, Depression, Hematopoietic and Lymphoid Cell Neoplasm, Myelodysplastic Syndrome
- Being tested
- Internet-Based Intervention, Medical Chart Review, Quality-of-Life Assessment, Questionnaire Administration
- Keywords
- stem cell transplant, cancer survivors, internet, social media, distress, health care adherence
- Medical subject headings
- Depression, Hematologic Neoplasms, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Receive full access to INSPIRE
Internet-Based InterventionOther
Receive access to an annotated list of existing resources for transplant and cancer survivors and delayed access to INSPIRE site
Medical Chart ReviewOther
Also called Chart Review
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (INSPIRE internet full program access) | Experimental | 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. Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (delayed program access control) | Experimental | Participants receive annotated website links to existing transplant and cancer survivor sites, followed by delayed access to the INSPIRE internet program after 1 year. Receives: Other: Internet-Based Intervention; Other: Medical Chart Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer and treatment distress (CTXD) score as reported on the PCA using binary outcomes
Measured: Up to 12 months
PHQ-8 depression score as reported on the PCA, using binary outcomes
Measured: Up to 12 months
Proportion of adherence to recommended survivorship preventive care and barriers to PCA
Measured: Up to 12 months
Secondary outcomes (3)
Health behaviors
Composite measure of health behaviors, including tobacco use, alcohol use, physical activity, use of sunscreen, food intake, body mass index, and sleep.
Measured: Up to 12 months
Physical function, as assessed by the Patient Reported Outcomes Measurement Information System scale
Measured: Up to 12 months
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study start14 May 2013
- Primary completion28 Nov 2016
- Study completion28 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen Syrjala, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602211
- Sponsor's protocol ID
- 2605.00
- Other IDs
- NCI-2012-00743, 2605.00, R01CA160684
- Acronym
- INSPIRE
- Status last verified
- Sep 2017
- First submitted
- 15 May 2012
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35662590Banerjee 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.
PubMed 32781287
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01602211
- Acronym / sponsor ID
- INSPIRE / 2605.00
- Conditions
- Cancer Survivor, Depression, Hematopoietic and Lymphoid Cell Neoplasm, Myelodysplastic Syndrome
- Keywords
- stem cell transplant, cancer survivors, internet, social media, distress, health care adherence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 May 2013 (actual)
- Primary completion
- 28 Nov 2016 (actual)
- Study completion
- 28 Nov 2016 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (INSPIRE internet full program access) | Experimental | Other: Internet-Based Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants 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 (delayed program access control) | Experimental | Other: Internet-Based Intervention, Other: Medical Chart Review, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants receive annotated website links to existing transplant and cancer survivor sites, followed by delayed access to the INSPIRE internet program after 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Received a transplant at a consortium center for a hematologic malignancy or myelodysplasia
- Currently 2-10 years after first HCT
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionReceive full access to INSPIRE | Other | Arm I (INSPIRE internet full program access) |
| Internet-Based InterventionReceive access to an annotated list of existing resources for transplant and cancer survivors and delayed access to INSPIRE site | Other | Arm II (delayed program access control) |
| Medical Chart ReviewAlso: Chart ReviewAncillary studies | Other | Arm II (delayed program access control) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (INSPIRE internet full program access), Arm II (delayed program access control) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (INSPIRE internet full program access), Arm II (delayed program access control) |
Primary outcome
Cancer and treatment distress (CTXD) score as reported on the PCA using binary outcomes
Time frame: Up to 12 months
PHQ-8 depression score as reported on the PCA, using binary outcomes
Time frame: Up to 12 months
Proportion of adherence to recommended survivorship preventive care and barriers to PCA
Time frame: Up to 12 months
3 secondary outcomes
Health behaviors
Time frame: Up to 12 months
Physical function, as assessed by the Patient Reported Outcomes Measurement Information System scale
Time frame: Up to 12 months
Total minutes per week of moderate to vigorous intensity exercise as assessed by the Godin Leisure Time Exercise Questionnaire
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Derived from this study: PubMed 35662590Farhadfar 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.
- Derived from this study: PubMed 32781287Banerjee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Syrjala principal investigator
Fred Hutch/University of Washington Cancer Consortium
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Internet-Based Intervention, Medical Chart Review and Quality-of-Life Assessment in people with Cancer Survivor and Depression, run by Fred Hutchinson Cancer Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer and treatment distress (CTXD) score as reported on the PCA using binary outcomes (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01602211, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.