Pursuing Exploration into the Supportive Care Needs and Intervention Preferences of Survivors of Testicular Cancer (PERSIST): A Mixed Methods Pilot Study
Shelley Johns
Primary Investigator
Brief description of study
Detailed description of study
What will happen during the study?
This three-phase mixed methods study will assess and address the unmet needs of TCS. Phase 1 is a cross-sectional survey study designed to assess the needs, symptoms, coping, quality of life, and intervention preferences of TCS through a quantitative survey (n=130) and a focus group interview for a sub-sample of up to 28 survey completers.
Focus group interviews, two of the intervention co-design meetings, and study interventions are designed to take place in subjects' homes. Two of the Phase 2 co-design meetings will be conducted in-person at an agreed upon, private location (such as a meeting room at the Regenstrief Institute). The two meetings held in person will be mutually determined by our study team and the research participants. All three interactions mentioned above will be delivered in a group-based video conference format via Zoom Health, a HIPAA-aligned videoconference platform.
Phase 1 Enrollment
Participants who are both interested and eligible will give verbal consent to participate in both Phase 1 study tasks (completing the quantitative survey and participating in a focus group interview) simultaneously, however survivors will be made aware that participation in a focus group interview is not guaranteed.
Quantitative Surveys: After providing verbal informed consent, enrolled participants (n=130 TCS) will be invited to complete a single 45-minute online quantitative survey (containing demographic items, clinical variables, and patient-reported outcome measures).
Focus Group Interview: After providing verbal consent, enrolled participants (n=28 TCS, which will ideally include participants who also answered the quantitative survey) will be asked to attend a single 90-minute focus group session via video conference.
Phase 2 Enrollment
After providing verbal consent, enrolled participants (n=8 TCS, which could include participants from Phase 1) will be asked to attend four collaborative intervention-design meetings over the course of approximately 8 weeks. We will strive to host two co-design meetings in person (2 hours each) and two meetings via videoconference (90 minutes each).
Phase 3 Enrollment
After providing verbal consent, enrolled participants (n=20 TCS, which could include participants from Phase 1, but CANNOT include participants from Phase 2) will be asked to complete three 40-minute surveys (see Section 3.0 for more details on specific measures and outcomes) and attend all intervention sessions (the total number of sessions to attend and the duration of each session will be determined in Phase 2).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Testicular Cancer, TCS
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Age: 18 years or above
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Gender: Male
Inclusion Criteria
(1) At least 18 years of age.
(2) Diagnosed with testicular cancer (any type, stage, or risk category) without evidence of active distant disease at time of study entry.
(3) Completed surgery, chemotherapy, radiation therapy, and/or stem cell transplant ≤5 years prior to enrollment.
(4) Willing to provide authorization to be contacted by email as nearly all study activities are conducted online through REDCap or Zoom Health.
(5) Willing to complete surveys.
(6) Willing to participate in a 90-minute focus group interview (if selected to participate in a Phase 1 focus group interview), four 90-minute intervention co-design meetings (if selected for study Phase 2), and/or the offered number of 90-minute intervention sessions (if selected to participate in study Phase 3), with all focus group interviews, co-design meetings, and intervention sessions offered via videoconference.
(7) Able to speak and read English.
(8) For Phase 3 only:
a. Patient has clinically significant FCR (FCR-7 score ≥17)55 and/or anxiety (GAD-7 score ≥10)42,71 at eligibility screening. 72
b. Primary resident of Indiana at the time of enrollment, with no plans to leave the state during the active intervention period.
Exclusion Criteria
(1) Completed surgery, chemotherapy, radiation therapy, and/or stem cell transplant < 2 weeks prior to enrollment (excluding to avoid acute toxicity side effects of treatment).
(2) Patient has co-morbidities or deficits that would impair participation in the study, including:
a. history of neurological disorder or traumatic brain injury (e.g., stroke, encephalitis, epilepsy, loss of consciousness >10 min);
b. severe depressive symptoms (PHQ-2 score ≥5 at screening);73
c. active substance abuse or uncontrolled bipolar disorder, schizophrenia, or psychosis;
d. obvious hearing and/or communicative disability that would impair their participation (Phase 1 focus group interviews and Phases 2 and 3 only).
(3) Patient is currently participating in “The Platinum Study” (PI: Lois Travis).
(4) For Phase 3 only:
a. Currently participating in psychotherapy focused on cancer-specific adjustment/support;
b. Currently participating in any behavioral/psychosocial research study that has the potential to skew results of this study or the study in which the patient is participating.
