Breast CarcinomaNCT04081779
Survivorship Care Plans and Telehealth Education for the Improvement of Access to Cancer Survivorship, the IMPACT Study
A study testing Survivorship Care Plan, Educational Intervention and Questionnaire Administration in people with Breast Carcinoma and Colorectal Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well self-generated survivorship care plans and telehealth education works in improving knowledge and self-efficacy in cancer survivors living in rural areas. Patients living in rural areas often face barriers to survivorship care and report unmet needs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma
- What is being tested?
- Survivorship Care Plan, Educational Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2020to 31 Mar 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cancer survivors who have completed curative therapy within the past 5 years (may still currently be on long-term/targeted non-cytotoxic agent maintenance therapy, e.g., tamoxifen or aromatase inhibitors for breast cancer survivors; androgen deprivation therapy for prostate cancer survivors)
- History of either adult-onset (age >= 18) lymphoma, breast, colorectal, lung, or prostate cancer
- Able to perform all study requirements, including responding to questionnaires
- Willing to be randomized
- Capable of providing informed consent
- Consent to release oncology and primary care medical records
Show all 10Show fewer
- English or Spanish speakers
- PRIMARY CARE PROVIDERS: PCPs responsible for delivering primary care to IMPACT study participants will be contacted about participating in the study after participant enrollment into the study.
- ONCOLOGY STAFF: Oncology Staff (Oncologists, Nurse Practitioners, Physician's assistants) will be recruited from sites involved in the IMPACT study
- CLINIC ADMINISTRATORS: Clinic administrators will be recruited from sites involved in the IMPACT study
Who cannot join
- Currently on palliative or hospice care, or considering transferring to such care within the next 3 months
- Lacks telephone access
- Lacks mailing address or ability to receive study materials electronically
- Currently being followed in a pediatric clinical setting (either for primary care or for cancer care)
- History of having had > 1 cancer type diagnosed and treated (exception is for skin cancers treated with surgical excision alone; also, individuals who only have had relapse of their initial cancer remain eligible so long as they have completed curative therapy and meet all other eligibility criteria)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: IMPACT: Improving Access to Cancer Survivorship Via Telehealth
This trial studies how well self-generated survivorship care plans and telehealth education works in improving knowledge and self-efficacy in cancer survivors living in rural areas. Patients living in rural areas often face barriers to survivorship care and report unmet needs. A survivorship care plan created by the patient (self-generated) may help them to better transition from oncology to primary care and improve communication between care teams in order to meet these needs and create better health outcomes. Telehealth is a way of delivering health care services from a distance, including patient education. Combining a self-generated survivorship care plan with telehealth education may help to improve knowledge and self-efficacy in cancer survivors.
Read the detailed description
OUTLINE:
Patients complete a questionnaire at baseline (paper, online, or telephone-based) and have medical records reviewed and are assigned to 1 of 3 cohorts.
COHORTS A AND B: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).
ARM II: Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors.
COHORT C: Patients are randomized to 1 of 3 arms.
ARM III: Patients receive generic information on survivorship care on study.
ARM IV: Patients receive generic information on survivorship care and a self-generated SCP as in Arm I on study.
ARM V: Patients receive generic information on survivorship care as well as a self-generated SCP as in Arm I and a telephone-based educational counseling session as in Arm II on study.
PRIMARY CARE PROVIDERS: Primary care providers complete a questionnaire about perceptions of the SCP and self-efficacy in providing survivorship care.
ONCOLOGY CLINICS: Participants complete Organizational Readiness to Change Assessment (ORCA) questionnaire and participate in a qualitative interview about perceptions of implementation of survivorship care.
After completion of study, patients are followed up at approximately 8 weeks.
- Being tested
- Survivorship Care Plan, Educational Intervention, Questionnaire Administration, Supportive Care
- Keywords
- Cancer survivors, survivorship care plans, primary care
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Lymphoma, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship Care PlanOther
Receive patient-generated SCP
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive telephone-based educational counseling session
Questionnaire AdministrationOther
Ancillary studies
Supportive CareOther
Also called Supportive Therapy, Symptom Management
Receive generic information on survivorship care
| Study group | Role | What they receive |
|---|---|---|
| Arm I (patient-generated SCP) | Active comparator | Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses). Receives: Other: Survivorship Care Plan; Other: Questionnaire Administration |
| Arm II (patient-generated SCP, counseling) | Experimental | Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors. Receives: Other: Survivorship Care Plan; Other: Educational Intervention; Other: Questionnaire Administration |
| Arm III (generic information) | Active comparator | Patients receive generic information on survivorship care on study. Receives: Other: Questionnaire Administration; Other: Supportive Care |
| Arm IV (generic information, patient-generated SCP) | Active comparator | Patients receive generic information on survivorship care and a self-generated SCP as in Arm I on study. Receives: Other: Survivorship Care Plan; Other: Questionnaire Administration; Other: Supportive Care |
| Arm V (generic information, patient-generated SCP, counseling) | Experimental | Patients receive generic information on survivorship care as well as a self-generated SCP as in Arm I and a telephone-based educational counseling session as in Arm II on study. Receives: Other: Survivorship Care Plan; Other: Educational Intervention; Other: Questionnaire Administration; Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial participation rate of cancer survivors identified from community-based or partner practices, and Cancer Surveillance System of Western Washington
Measured: Up to 8 weeks
Accuracy of survivors' self-generated survivorship care plans (SCPs) in relation to those based on medical record abstraction
Will measure the accuracy of participants' SCPs by comparing their self-reported medical history collected via questionnaire, with data abstracted from medical records. Accuracy will be reported by percentage of missing data in the self-generated SCP compared to medical records, and percentage of incorrect data in the self-generated SCP compared to medical records.
Measured: Up to 8 weeks
Proportion of survivors who receive the phone-based education session within the study time period
Measured: Up to 8 weeks
Proportion of survivors who complete the follow-up questionnaire within the study time period
Measured: Up to 8 weeks
Response rate among primary care providers (PCPs) to the PCP survey
Measured: Up to 8 weeks
Secondary outcomes (4)
Participant perceived self-efficacy: questionnaire using the PROMIS Global 10 and health related self-efficacy scales
The effects of the intervention versus (vs.) control on participant perceived self-efficacy will be measured at baseline and at the end of the study via a questionnaire using the PROMIS Global 10 and health related self-efficacy scales.
Measured: Up to 8 weeks
Survivorship knowledge
The effects of the intervention vs. control on survivorship knowledge will be measured at baseline and at the end of the study via a questionnaire.
Measured: Up to 8 weeks
PCP self-efficacy towards survivorship care
The effects of the intervention vs. control on PCP self-efficacy towards survivorship care will be measured at baseline and at the end of the study via a questionnaire using the PROMIS Global 10 and health related self-efficacy scales.
Measured: Up to 8 weeks
Local oncology clinics' attitudes towards survivorship care implementation
Assess oncology practitioners' and clinic administrators' views on utility and feasibility of implementing SCPs in target clinics, using the ORCA (Organizational Readiness to Change Assessment) instrument and qualitative interviewing
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start19 Feb 2020
- Primary completion31 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eric Chow, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081779
- Sponsor's protocol ID
- RG1005815
- Other IDs
- NCI-2019-05726, 10267, P30CA015704, R21CA258105
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2019
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yi JC, Lee E, Duggan C, Baker KS, Blythe N, Cole AM, Cushing-Haugen KL, Gutierrez AI, Linden H, Mendoza JA, Ohlsen TJD, Ortblad KF, Schwartz SM, Yung R, Ceballos R, Chow EJ. Perspective of Hispanic Cancer Survivors on Survivorship Care Plans: A Qualitative Study. J Immigr Minor Health. 2026 Apr;28(2):384-392. doi: 10.1007/s10903-025-01794-8. Epub 2025 Oct 14.
PubMed 41087806Chow EJ, Blythe NA, Cushing-Haugen KL, Duggan C, Baker KS, Cole AM, Green S, Guiterrez AI, Lee E, Linden HM, Mendoza JA, Ohlsen TJD, Ortblad KF, Schwartz SM, Yung RL, Ceballos RM. Enhancing survivorship care among Hispanic/Latino cancer survivors via lay health educators: results of a pilot randomized trial. J Cancer Surviv. 2026 Aug;20(4):1591-1600. doi: 10.1007/s11764-025-01758-9. Epub 2025 Feb 15.
PubMed 39955465Duggan C, Cushing-Haugen KL, Cole AM, Allen J, Gilles R, Hornecker JR, Gutierrez AI, Warner J, Baker KS, Ceballos RM, Chow EJ. Feasibility of delivering survivorship care via lay health educators: A pilot randomized controlled trial among rural cancer survivors. J Rural Health. 2023 Jun;39(3):666-675. doi: 10.1111/jrh.12736. Epub 2023 Jan 2.
PubMed 36593127
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT: Improving Access to Cancer Survivorship Via Telehealth
- ClinicalTrials.gov ID
- NCT04081779
- Acronym / sponsor ID
- RG1005815
- Keywords
- Cancer survivors, survivorship care plans, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 9 Sep 2019 (actual)
- 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 trial studies how well self-generated survivorship care plans and telehealth education works in improving knowledge and self-efficacy in cancer survivors living in rural areas. Patients living in rural areas often face barriers to survivorship care and report unmet needs. A survivorship care plan created by the patient (self-generated) may help them to better transition from oncology to primary care and improve communication between care teams in order to meet these needs and create better health outcomes. Telehealth is a way of delivering health care services from a distance, including patient education. Combining a self-generated survivorship care plan with telehealth education may help to improve knowledge and self-efficacy in cancer survivors.
Detailed description
OUTLINE:
Patients complete a questionnaire at baseline (paper, online, or telephone-based) and have medical records reviewed and are assigned to 1 of 3 cohorts.
COHORTS A AND B: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).
ARM II: Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors.
COHORT C: Patients are randomized to 1 of 3 arms.
ARM III: Patients receive generic information on survivorship care on study.
ARM IV: Patients receive generic information on survivorship care and a self-generated SCP as in Arm I on study.
ARM V: Patients receive generic information on survivorship care as well as a self-generated SCP as in Arm I and a telephone-based educational counseling session as in Arm II on study.
PRIMARY CARE PROVIDERS: Primary care providers complete a questionnaire about perceptions of the SCP and self-efficacy in providing survivorship care.
ONCOLOGY CLINICS: Participants complete Organizational Readiness to Change Assessment (ORCA) questionnaire and participate in a qualitative interview about perceptions of implementation of survivorship care.
After completion of study, patients are followed up at approximately 8 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm I (patient-generated SCP) | Active comparator | Other: Survivorship Care Plan, Other: Questionnaire AdministrationPatients receive a self-generated SCP (i.e., generated from baseline questionnaire responses). |
| Arm II (patient-generated SCP, counseling) | Experimental | Other: Survivorship Care Plan, Other: Educational Intervention, Other: Questionnaire AdministrationPatients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors. |
| Arm III (generic information) | Active comparator | Other: Questionnaire Administration, Other: Supportive CarePatients receive generic information on survivorship care on study. |
| Arm IV (generic information, patient-generated SCP) | Active comparator | Other: Survivorship Care Plan, Other: Questionnaire Administration, Other: Supportive CarePatients receive generic information on survivorship care and a self-generated SCP as in Arm I on study. |
| Arm V (generic information, patient-generated SCP, counseling) | Experimental | Other: Survivorship Care Plan, Other: Educational Intervention, Other: Questionnaire Administration, Other: Supportive CarePatients receive generic information on survivorship care as well as a self-generated SCP as in Arm I and a telephone-based educational counseling session as in Arm II on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Cancer survivors who have completed curative therapy within the past 5 years (may still currently be on long-term/targeted non-cytotoxic agent maintenance therapy, e.g., tamoxifen or aromatase inhibitors for breast cancer survivors; androgen deprivation therapy for prostate cancer survivors)
- History of either adult-onset (age >= 18) lymphoma, breast, colorectal, lung, or prostate cancer
- Able to perform all study requirements, including responding to questionnaires
- Willing to be randomized
- Capable of providing informed consent
Key exclusion criteria (5 listed)
- Currently on palliative or hospice care, or considering transferring to such care within the next 3 months
- Lacks telephone access
- Lacks mailing address or ability to receive study materials electronically
- Currently being followed in a pediatric clinical setting (either for primary care or for cancer care)
- History of having had > 1 cancer type diagnosed and treated (exception is for skin cancers treated with surgical excision alone; also, individuals who only have had relapse of their initial cancer remain eligible so long as they have completed curative therapy and meet all other eligibility criteria)
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 |
|---|---|---|
| Survivorship Care PlanReceive patient-generated SCP | Other | Arm I (patient-generated SCP), Arm II (patient-generated SCP, counseling), Arm IV (generic information, patient-generated SCP), Arm V (generic information, patient-generated SCP, counseling) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive telephone-based educational counseling session | Other | Arm II (patient-generated SCP, counseling), Arm V (generic information, patient-generated SCP, counseling) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (patient-generated SCP), Arm II (patient-generated SCP, counseling), Arm III (generic information), Arm IV (generic information, patient-generated SCP), Arm V (generic information, patient-generated SCP, counseling) |
| Supportive CareAlso: Supportive Therapy, Symptom ManagementReceive generic information on survivorship care | Other | Arm III (generic information), Arm IV (generic information, patient-generated SCP), Arm V (generic information, patient-generated SCP, counseling) |
Primary outcome
Initial participation rate of cancer survivors identified from community-based or partner practices, and Cancer Surveillance System of Western Washington
Time frame: Up to 8 weeks
Accuracy of survivors' self-generated survivorship care plans (SCPs) in relation to those based on medical record abstraction
Time frame: Up to 8 weeks
Will measure the accuracy of participants' SCPs by comparing their self-reported medical history collected via questionnaire, with data abstracted from medical records. Accuracy will be reported by percentage of missing data in the self-generated SCP compared to medical records, and percentage of incorrect data in the self-generated SCP compared to medical records.
Proportion of survivors who receive the phone-based education session within the study time period
Time frame: Up to 8 weeks
Proportion of survivors who complete the follow-up questionnaire within the study time period
Time frame: Up to 8 weeks
Response rate among primary care providers (PCPs) to the PCP survey
Time frame: Up to 8 weeks
4 secondary outcomes
Participant perceived self-efficacy: questionnaire using the PROMIS Global 10 and health related self-efficacy scales
Time frame: Up to 8 weeks
Survivorship knowledge
Time frame: Up to 8 weeks
PCP self-efficacy towards survivorship care
Time frame: Up to 8 weeks
Local oncology clinics' attitudes towards survivorship care implementation
Time frame: Up to 8 weeks
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 8 Apr 2026.
- Derived from this study: PubMed 41087806Yi JC, Lee E, Duggan C, Baker KS, Blythe N, Cole AM, Cushing-Haugen KL, Gutierrez AI, Linden H, Mendoza JA, Ohlsen TJD, Ortblad KF, Schwartz SM, Yung R, Ceballos R, Chow EJ. Perspective of Hispanic Cancer Survivors on Survivorship Care Plans: A Qualitative Study. J Immigr Minor Health. 2026 Apr;28(2):384-392. doi: 10.1007/s10903-025-01794-8. Epub 2025 Oct 14.
- Derived from this study: PubMed 39955465Chow EJ, Blythe NA, Cushing-Haugen KL, Duggan C, Baker KS, Cole AM, Green S, Guiterrez AI, Lee E, Linden HM, Mendoza JA, Ohlsen TJD, Ortblad KF, Schwartz SM, Yung RL, Ceballos RM. Enhancing survivorship care among Hispanic/Latino cancer survivors via lay health educators: results of a pilot randomized trial. J Cancer Surviv. 2026 Aug;20(4):1591-1600. doi: 10.1007/s11764-025-01758-9. Epub 2025 Feb 15.
- Derived from this study: PubMed 36593127Duggan C, Cushing-Haugen KL, Cole AM, Allen J, Gilles R, Hornecker JR, Gutierrez AI, Warner J, Baker KS, Ceballos RM, Chow EJ. Feasibility of delivering survivorship care via lay health educators: A pilot randomized controlled trial among rural cancer survivors. J Rural Health. 2023 Jun;39(3):666-675. doi: 10.1111/jrh.12736. Epub 2023 Jan 2.
- Individual participant dataSharing planned: No
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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.
Eric Chow principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivorship Care Plan, Educational Intervention and Questionnaire Administration in people with Breast Carcinoma and Colorectal Carcinoma, run by Fred Hutchinson Cancer Center at 1 site 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 10 inclusion and 5 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Initial participation rate of cancer survivors identified from community-based or partner practices, and Cancer Surveillance System of Western Washington (time frame: Up to 8 weeks). The study lists 5 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 NCT04081779, which also lists 3 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 8 Apr 2026.