Symptoms and General Pathology

All Conditions

Recurrence

Disease Attributes

Participants will receive 7 weekly group therapy sessions consisting of psychoeducation on fear of cancer recurrence, relaxation training, CBT, and evidenced-based tips to decrease avoidance and anxiety surrounding fear of cancer recurrence.

Participants assigned to this arm wait about 3-months to receive the intervention.

7 weekly sessions of 90-120 minutes each. During the 7 weeks, participants will be asked to participate in activities, participate in group discussions, and complete homework assignments.

Family Caregiver - Fear Of Recurrence Therapy (FC-FORT)

Sophie Lebel, PhD

Fear of cancer recurrence (FCR) is common, persistent, and is associated with negative outcomes. Studies show that family caregivers (FC) of cancer patients experience equal or greater levels of FCR than patients themselves. In the past 5 years, several interventions have demonstrated their ability to reduce FCR among cancer patients, including a group intervention called Fear of Recurrence Therapy (FORT). However, none have ever been adapted and offered to caregivers. The goals of the proposed study are to demonstrate 1) that a newly adapted intervention of FORT (FC-FORT) is feasible (i.e., participant recruitment, attendance and participation) and acceptable (i.e., FC satisfaction of the intervention) for a larger study, and 2) the clinical implications of FC- FORT on FCR and quality of life. An advisory board composed of researchers, therapists, and FC was created to adapt FORT for FC and to an online format. FC and therapists are currently being recruited to conduct a usability study of the newly adapted FC-FORT. They will be asked to complete a session feedback questionnaire after each session and to take part in an exit interview. The content of these will be summarized back to the advisory board in order to further refine FC-FORT. Following a successful usability study, FC-FORT will be given to four groups of nine new FC (pilot study). Participants will be recruited directly by clinicians and by outreach mailout efforts. They will complete a questionnaire package before and after the intervention, as well as at a three month follow up. The proposed study is needed to determine if an already developed FCR intervention can be adapted to family caregivers and if it can be successfully pilot tested. This will help bridge an important gap in bringing evidence-based care to caregivers who have never been offered help before for their FCR. The proposed project will also allow to further feasibility and acceptability of E-Health interventions.

Usability Study

6-8 female family caregivers will be recruited to conduct a usability study of this first version of FC-FORT. Participants will be recruited through the University of Ottawa, the Princess Margaret Cancer Centre, community partners and social media. Two therapists with extensive experience with online support groups to conduct the sessions will be recruited to conduct the groups. Therapist competency to administer FC-FORT will be determined by registered professionals in counselling or psychotherapy, at least 5 years of experience in psychosocial oncology, and having led at least one group. These therapists will receive an online training from the principal investigators before starting the usability study. Interested family caregivers will contact the research coordinator, via telephone or email, to be screened for eligibility and to complete the consent forms. All eligible participants will attend a one-on-one pre-therapy meeting to prepare them for the group work (i.e.: review expectations and assess whether group work is appropriate for the participant) and complete the 7-week FC-FORT intervention. Before starting the intervention, participants will receive a standardized manual describing each session's activities and assignments. After each of the seven sessions, the therapists and the participants will be asked to complete a short session feedback questionnaire, via Qualtrics, to assess the usefulness, usability, desirability, value, accessibility, and credibility of the session, as well as about participants' impressions of the online format and features, and the general readiness of the session for end users. Brief videoconference or telephone exit interviews will be conducted post-intervention with both the participating family caregivers and the therapists. The content of these interviews and questionnaires will be summarized and present it back to the project's advisory board in order to further refine the FC-FORT content and format.

Pilot Study

36 family caregivers will be recruited to participate in the study. Additionally, 3 therapists with extensive online support group experience to conduct the FC-FORT videoconference therapy sessions. Therapist competency to administer FC-FORT will be determined by registered professionals in counselling or psychotherapy, at least 5 years of experience in psychosocial oncology, and having led at least one group. Interested family caregivers will contact the research coordinator, via telephone or email, to be screened for eligibility and to complete the consent forms. This pilot study will serve as a first step in potential sample size calculations and recruitment times. For this pilot study, active recruitment will last for a period of 15 months during which 36 FC are aimed to be recruited in order to create 4 groups of 9 participants (2 intervention conditions and 2 WLCG). Feasibility of recruitement for the larger RCT will be determined using these critera: 1) If during our recruitment period less than 18 participants, recruitement for a larger RCT, using our current recruitment strategies, will be deemed not feasible, 2) If between 18 and 25 participants are recruited, then a larger multicentre approach for recruitment will be considered, 3) If recruit 25 participants or more, recruitement for a larger RCT, using our current methods, will be deemed feasible. The sample size will be reevaluated for the larger RCT based on the results from this pilot study.

FC-FORT consists of 7 consecutive weekly group sessions of 90-120 minutes each offered through videoconference and weekly assigned homework. FC-FORT is therapist led, however participants will receive a workbook where they can follow along, take notes, and complete the exercises and the homework assignments. The overall aim of FC-FORT is to guide FC towards a more manageable level of worry and fear of recurrence. The key goals are to: 1) distinguish worrisome symptoms from benign ones; 2) identify FCR triggers and inappropriate coping strategies; 3) facilitate the learning and use of new coping strategies, such as relaxation techniques, cognitive restructuring, communication strategies and the use of self-care; 4) increase tolerance for uncertainty; 5) promote emotional expression of specific fears that underlie FCR; and 6) re-examine life priorities and set realistic goals for the future. Each session is composed of exercices where participants have to answer questions, share with the group or watch videos. Furthermore, homework is assigned after each session to be completed before next week's session. Eligible participants will attend a one-on-one pre-therapy meeting with a study therapist to prepare them for the group work (i.e.: review expectations and assess whether group work is appropriate for the participant) and complete the 7-week FC-FORT intervention. Membership will be closed once groups are formed and the sessions have started to enhance group cohesiveness and consistency. Before starting the intervention, participants will receive a standardized manual describing each session's activities and assignments. All participants (including those in the wait list control group) will complete a questionnaire package pre intervention, post intervention, and at a three month follow up via Qualtrics. Additionally, participants will be asked to complete post session measures, namely the Working Alliance Inventory - Revised Short Form as well as the Group Cohesiveness Scale after the 1st, 4th and 7th sessions.

Therapist Training and Supervision.

To enhance therapist adherence to treatment, the therapists recruited for the study will be provided with a standardized FC-FORT manual and will be trained by the research psychologists through an online training. The research team will review the video of each session and the principal investigator will provide weekly 30-minute supervision to the therapists. Furthermore, the study will use an updated version of the fidelity checklist that was used to evaluate adherence during the previous FORT studies. If adherence is less than 80% on any session, the research team will provide additional over-the-telephone feedback to the therapists running the group. This approach to monitoring treatment integrity and fidelity has been successful in previous FORT studies.

Qualitative Assessment.

To gain further insights about the feasibility, acceptability, and potential clinical significance of the FC-FORT, all study participants will be asked to complete semi structured interviews. This will enable a holistic understanding of their experience of FC-FORT, elucidate key intervention processes, and identify additional secondary outcomes. Lastly, the research coordinator will attempt to interview participants who dropped out of the intervention, to understand any hindering factors. Consenting participants will be asked to complete a semi structured interview (30-60 minutes) about their experience of the intervention through videoconferencing.

Randomization

This study will use a mixed method randomized control trial design using a waitlist control group and 3 months follow up, with 18 participants per condition. To minimize attrition associated with waiting to enroll participants, block randomization will be used. Specifically, a list of 4 blocks with equal numbers of intervention (I) and wait list control (WLCG) groups (e.g. I-I-WLCG-WLCG; I-WLCG-WLCG-I, etc.) will be randomly created. Once the first 9 participants have been recruited, they will be assigned to whichever group came up first on the list. The next 9 participants will be assigned to the next group on the generated list until all 4 groups have been completed. Participants assigned to the WLCG will be offered the intervention after the 3-month period. To limit bias, each of the 4 blocks of the list will be in separate sealed envelopes that will be opened one at a time after 9 participants have been recruited.

Minimizing Dropouts and Attrition

To maximize attendance, as in our prior research, participants will be told during informed consent procedures about the importance of attending all 7 sessions to ensure benefit from the intervention. Participants will receive two email reminders about each upcoming session, along with "homework" and session pre-reading materials. They will be asked to inform group therapists if they are to be absent. For participants who miss a session, they will be offered one individual videoconference make-up session for their first missed session before the next group; they will not be offered subsequent make-up sessions for additional missed sessions to decrease the risk that this would encourage those who prefer individualized attention to miss group sessions. Participants who miss more than two sessions will be asked to stop the intervention and restart with the next available group. This approach was successfully tested in previous FORT studies. To minimize differential attrition from the WLCG participants, participants will be emailed monthly with an update about the wait time.

Feasibility and Acceptability Criteria.

The following criteria will be used to assess the feasibility and acceptability of FC-FORT: 1) ability to recruit 36 FC in 15 months; 2) ability to randomize these 36 FC; 3) ability to deliver FC-FORT to 27 FC in 15 months (25% dropout rate); 4) 80% completion of 6 out of the 7 sessions; 5) complete measures for 90% of participants; 6) ability to deliver FC-FORT as intended as measured by a fidelity rating of above 80% on 75% of reviewed sessions; and 7) FC satisfactory ratings \>than 80% in terms of its content, therapists, and mode of delivery.

Quantitative analysis.

Descriptive statistics will be used to report on FCR outcomes. A linear mixed-effect model analyses will be done on the secondary outcome measures pre- and post-intervention and at the 3-month follow-up. All analyses will use both an intent-to-treat and per protocol approaches. Known extraneous variables that could influence FCR (e.g., age, education, income, cancer stage) will be measured and control for, and monitor for participants' use of any additional psychological support at each data-collection time-points. Dependence of the group data will be analyzed with an intraclass correlation coefficient (p) using a multilevel model.

Qualitative Analysis.

Conventional content analysis will be used to analyse the qualitative data. Interviews will be audiotaped, transcribed verbatim, and managed using the qualitative software program NVivo. Transcripts will be systematically coded into anticipated (e.g., motivations to participate, benefits of participation) and emergent codes. This is an iterative process whereby an initial set of themes are coded, applied to new transcripts, and revised to adjust for new information, until no new codes emerge. Double coding of 80% of the interviews will be done by the research assistant. These codes will then be sorted into subcategories (ideally between 10 to 15).

It's Time to Address Fear of Cancer Recurrence in Family Caregivers: Online Version of the Fear Of Recurrence Therapy

It Is Time to Address Fear of Cancer Recurrence in the Family Caregiver: Adaptation, Feasibility, and Acceptability Study of an Online Version of the Fear Of Recurrence Therapy

Fear of Cancer Recurrence Inventory - Short Form (FCR-SF), range from 0-36 with higher scores indicating high levels of fear of cancer recurrence

Intolerance of Uncertainty Scale - Short Form (IUS-SF), range from 12-60 with higher scores indicating high levels of intolerance of uncertainty

Mishel Uncertainty in Illness Scale Short-Form, range from 5-25 with higher scores indicating high levels of uncertainty in illness

Why Worry Questionnaire (WWQ), range from 13-65 with higher scores indicating more positive beliefs about worrying

Cognitive Avoidance Questionnaire (CAQ), range from 25-125 with higher scores indicating higher use of avoidance as a coping strategy

Protective Buffering Scale (PBS), range from 10-50 with higher scores indicating high levels of protective buffering

Working Alliance Inventory - Revised Short Form (WAI-R-SF), Range from 12-60 with higher scores indicating a stronger therapeutic alliance

Group Cohesiveness Scale (GCS), Range from 7-35 with higher score indicating a stronger group cohesion

University of Ottawa

Professor

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants received the cognitive behavioral stress management intervention for 10 weeks.

Participants received the health promotion group for one day.

Participants will receive in-person weekly stress management group sessions (3-8 participants) for two hours per week for ten weeks total. Each session will consist of a half hour of relaxation training and one and a half hours of stress management skill training, including coping effectiveness training, anger management, assertiveness training, and stress awareness.

Cognitive behavioral stress management

Participants will receive one four-hour seminar in-person groups (3-8 participants) of educational information related to prostate cancer and abbreviated psychological information provided in cognitive behavioral stress management.

Psychoeducational Control

Michael H Antoni, Ph.D.

The purpose of this study is to test a stress management program for men with early-stage prostate cancer.

Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

The Measure of Current Status questionnaire is a 23-item questionnaire each scored on a range of 0-4. The total score ranges from 0-92 with the higher score corresponding to greater perceived abilities.

The Benefit Finding Scale questionnaire is a 17-item measure capturing perception of a traumatic event (e.g., cancer diagnosis for participants) with each item scored on a scale of 1 to 5. The total score ranges from 17-85 with the higher score corresponding to greater perceived benefit.

The Life Orientation Test - Revised questionnaire measures participant's optimism. The total score ranges from 0-24 with the higher score corresponding to greater levels of optimism.

Immune cell count (including T-cell (Cluster of Differentiation (CD) 3+) and T-helper cells (CD 3+ CD 4+) will be evaluated from blood samples. Both values will be evaluated in count per cubic millimeter.

Immune cell percentage (including T-cell (Cluster of Differentiation (CD) 3+) and T-helper cells (CD 3+ CD 4+) will be evaluated from blood samples. Both values evaluated in count per cubic millimeter over total cell count per cubic millimeter.

Natural killer cell (CD56+CD3-) percentage is evaluated from blood samples. Values are evaluated in count per cubic millimeter over total cell count per cubic millimeter.

Natural killer cell (CD56+CD3-) count is evaluated from blood samples. Values are evaluated in count per cubic millimeter.

Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples. Cells are stimulated through exposure to a reactive cell line and the percentage of cells active are counted and divided by total cells present per cubic millimeter.

Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples. Cells are stimulated through exposure to a reactive cell line and quantified as the ratio of responsive to unresponsive cells required to kill 10% of the target cell line.

Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples. Cells are stimulated through exposure to a reactive cell line and incubated for four hours total. Kinetic lytic index is quantified as the count of targeted cells killed during incubation. An average count of these cells will be calculated.

University of Miami

Behaviors and Mental Disorders

Anxiety Disorders

Patients in the group therapy arm will be enrolled in group therapy and be issued surveys.

Patients in control arm will be issued surveys

Twelve 1-hour group therapy sessions with a licensed psychologist for prostate-cancer related anxiety.

Group therapy

Surveys

Aaron Pinkhasov, MD

This study is a clinical trial to determine whether a 12-week group therapy intervention for patients undergoing Active Surveillance for Prostate Cancer can relieve disease-related anxiety and improve quality of life and delay elective treatment of prostate cancer. The goal of the study is to further our understanding of anxiety in men who have been diagnosed with prostate cancer and are undergoing Active Surveillance. Men who have elected Active Surveillance for their management of prostate cancer are eligible to participate in this study. After signing informed consent, all participants will complete two brief questionnaires (The Memorial Anxiety Scale for Prostate Cancer \[MAX-PC\] and the General Anxiety and Depression Scale 7 \[GAD-7\] to measure their anxiety levels. If the participant scores above a certain number, they will be asked to participate in the study. Patients will be randomly assigned to either a control group, who will receive no treatment, but continue to follow up with their urologist to manage their prostate cancer as usual, or the treatment group. The treatment group will receive 12 one-hour group therapy sessions that will take place once a week for 12 weeks with a licensed psychologist free of charge. They will be instructed to follow up with their urologist as previously determined for their prostate cancer management. Patients in both groups will be monitored for anxiety completing three questionnaires, the MAX-PC and GAD-7 which they previously completed, and the Functional Assessment of Cancer Therapy - Prostate (FACT-P) during the 4th and 12th weeks of therapy. If patients require further therapy beyond the group treatment sessions, the investigators may refer them to a psychologist or psychiatrist for further treatment.

A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance

Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their MAX-PC questionnaire scores. Eighteen questions about anxiety related to prostate cancer and prostate specific antigen (PSA) tests are graded from 0-3 (0 = not at all; 3 = often), yielding a total between 0 and 54.

Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their FACT-P questionnaire scores. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.

In secondary analysis, a mixed effects model will be used when the outcome vector consists of all three measurements (baseline, 4 and 12 weeks) and via statistical contrasts will examine whether the relationship between PSA anxiety scores and time is linear or if the effect of intervention on anxiety scores is fully observed by week 4. Two-sided p-values ≤ 0.05 will be considered statistically significant.

NYU Langone Health

Meaning Centered Group Psychotherapy (MCGP)

standardized Supportive Group Psychotherapy

this eight-week (1 ½ hour weekly sessions) Session 1 - Concepts of Meaning and Sources of Meaning Session 2 - Cancer and Meaning Session 3 - Meaning and Historical Context of Life Session 4 - Storytelling, Legacy Project (optional) Session 5 - Limitations and Finiteness of Life Session 6 - Responsibility, Creativity, Deeds Session 7 - Experience, Nature, Art, Humor Session 8 - Transitions, Goodbyes, Hopes for the Future

Meaning Centered Group Psychotherapy

The eight weekly 1 ½ hour sessions will focus on group discussion on a set of specific themes that emerge for patients coping with cancer. The session themes or topics will include such issues as: the discussion of strategies for coping with medical issues and procedures, communication with health care providers and issues related to family, friends, and occupational life.

Supportive Group Psychotherapy

William Breitbart, MD

The purpose of this study is to compare two types of group counseling for cancer patients: Meaning-Centered counseling and Supportive counseling. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" group counseling is intended to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" group counseling is intended to help you cope with cancer by giving you a place to express your feelings and get support from other cancer patients. The purpose of this study is to compare the benefits of these two types of counseling approaches for cancer patients.

To conduct a randomized controlled trial comparing the efficacy of Meaning-Centered Group Psychotherapy (MCGP) versus a standardized Supportive Group Psychotherapy (SGP) in reducing psychological distress (depression and anxiety), end-of-life despair (hopelessness, desire for hastened death, and suicidal ideation), and improving spiritual well-being and overall quality of life in a sample patients with advanced cancer.

To assess the relative impact of Meaning-Centered Group Psychotherapy on different aspects of spiritual well-being (e.g., a sense of meaning and purpose versus spirituality linked to religious faith).

To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy (e.g., potential mediating and moderating influences such as illness severity, religion and religiosity, level of education, race/ethnicity, level of pre-intervention social support, presence of pain and physical symptom burden).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
It's Time to Address Fear of Cancer Recurrence in Family Caregivers: Online Version of the Fear Of Recurrence Therapy	NCT05441384	Cancer Caregiver CBT Fear Cancer	Family Caregive...	18 Years -	University of Ottawa
Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer	NCT05486754	Stress	Cognitive behav... Psychoeducation...	50 Years -	University of Miami
A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance	NCT03227744	Prostate Cancer	Group therapy Surveys	40 Years -	NYU Langone Health
A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance	NCT03227744	Prostate Cancer	Group therapy Surveys	40 Years -	NYU Langone Health
Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients	NCT00494910	Palliative Care	Meaning Centere... Supportive Grou...	21 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for group therapy