Cancer Survivors > Adaptive Symptom Management And Survivorship Handbook (SMSH) And Telephone Interpersonal Counseling (TIP-C)
SMSH + TIP-C for Cancer Survivors' Well-being
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Arizona
Disqualifiers: Psychotic disorder, Bedridden, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a guidebook for managing symptoms and phone counseling for emotional support in cancer survivors and their caregivers, especially those in rural areas. The guidebook offers practical advice, while the counseling helps reduce stress and anxiety.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment SMSH + TIP-C for Cancer Survivors' Well-being?
Research shows that telephone counseling and self-management interventions can improve the quality of life and coping skills for cancer survivors. For example, a study on telephone counseling for breast cancer survivors found it helped with mood, social support, and self-efficacy. Additionally, self-management interventions have been beneficial in helping survivors manage their health and well-being post-treatment.
12345Is the SMSH + TIP-C treatment safe for cancer survivors?
The telephone counseling interventions, like those used in the SMSH + TIP-C treatment, have been tested in cancer survivors and are generally considered safe, focusing on improving quality of life and providing psychological support.
13467How is the SMSH + TIP-C treatment different from other treatments for cancer survivors?
The SMSH + TIP-C treatment is unique because it combines a handbook for managing symptoms and survivorship with telephone counseling to support cancer survivors' well-being. This approach is novel as it simultaneously addresses both psychosocial and health behavior outcomes through personalized support, which is not commonly found in other treatments.
34689Eligibility Criteria
This trial is for adult cancer survivors who've finished treatment within the last 2 years and their caregivers. Participants must have telephone access, not be in therapy, be able to do daily tasks, and understand English or Spanish. Caregivers can be of any relation.Inclusion Criteria
I finished my cancer treatment aimed at curing it between 4 weeks and 2 years ago.
I am aware of the current time, where I am, and who I am.
I can speak and understand either English or Spanish.
+9 more
Exclusion Criteria
Caregivers: Currently treated for cancer to preserve the distinguishability of 'survivor' and 'caregiver'
I am currently in counseling or psychotherapy.
I am a caregiver and I am under 18.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive weekly phone calls for symptom management and assessment using the General Symptom Management Scale (GSDS) over 16 weeks
16 weeks
16 weekly phone calls
Follow-up
Participants are monitored for safety and effectiveness after treatment, including two exit interviews
8 weeks
2 exit interviews at weeks 17 and 24
Participant Groups
The study tests two phone-based supports: a Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C), compared with receiving an NCI brochure on managing post-treatment needs.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Adaptive Need-based Sequence
Group II: Attention controlActive Control1 Intervention
This group will be participants that were randomized to the "Attention control" arm and will not receive the SMSH + TIP-C adaptive intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
KRMC WL Nugent Cancer CenterKingman, AZ
University of ArizonaTucson, AZ
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Who Is Running the Clinical Trial?
University of ArizonaLead Sponsor
American Cancer Society, Inc.Collaborator
References
Survivorship care planning after participation in communication skills training intervention for a consultation about lymphoma survivorship. [2018]A survivorship care plan refers to a written summary of the treatment received and recommendations regarding surveillance and management of late effects. To provide evaluation of a communication skills training (CST) intervention to enhance the transition of lymphoma survivors to cancer survivorship. Nineteen oncologists specializing in lymphoma treatment were recruited and completed a survivorship CST workshop, and two standardized patient assessments (SPAs), one pretraining and one posttraining. Significant improvements in SPA scores were observed in six of the seven SPA assessment categories: use of survivorship care plan, review of disease and treatment details, long-term effects, potential late effects, specific physician recommendations, and additional health maintenance recommendations. The intervention had significant effects on physicians' uptake of new strategies and skills, as measured through pre- and posttraining SPAs, as well as on the physicians' self-efficacy about having these conversations.
Qualitative experiences of breast cancer survivors on a self-management intervention: 2-year post-intervention. [2017]Increasing survivorship warrants evidence-based intervention to help women manage living effectively with breast cancer. Breast cancer survivors may have many medical and psychosocial issues in the post- treatment period. Qualitative research was carried out to assess survivors' overall experience and if intervention helps in survivorship care. This paper reports exploration of benefit-findings from participation in an earlier 4-week self management intervention.
Bridging the transition from cancer patient to survivor: pilot study results of the Cancer Survivor Telephone Education and Personal Support (C-STEPS) program. [2021]To develop a feasibility study of a theory-driven telephone counseling program to enhance psychosocial and physical well-being for cancer survivors after treatment.
Telephone counseling of breast cancer patients after treatment: a description of a randomized clinical trial. [2007]The Telephone Counseling Trial for Breast Cancer Survivors is a randomized, controlled study designed to test the impact of a telephone-based counseling intervention on quality of life of early-stage breast cancer patients who have completed adjuvant treatment. A psychoeducational counseling model is utilized to promote adaptive coping to re-entry stressors and survivorship issues. Adaptation is fostered through the exploration of thematic materials, application of active coping strategies, encouragement of a personal expression of the breast cancer experience and the provision of psychological support. Patients are being recruited in collaboration with two NCI-designated clinical cooperative oncology groups: the Eastern Cooperative Oncology Group (ECOG) and the Southwest Cooperative Oncology Group (SWOG). The recruitment goal is 400 breast cancer survivors with Stage 1, Stage 2 and Stage 3 disease (with no greater than 10 positive lymph nodes involved). Patients are being enrolled by data managers on-site during their last treatment visit. The intervention is being delivered by the Cancer Information and Counseling Line (CICL) of the AMC Cancer Research Center. It includes 16 telephone outcalls which are delivered over a 12-month period. Primary outcome measures are quality of life, mood, social support, self-efficacy, and sexual functioning, assessed at baseline, 3, 6, 12 and 18 months follow-up. This article provides a description of the intervention protocol and study design. It is argued that this study could provide a model for developing and testing other psychosocial interventions within clinical cooperative groups nationwide.
Exploring the use of the survivorship consult in providing survivorship care. [2021]Advances in breast cancer treatment have increased survival and contributed to longer periods of survivorship as reported by the Committee CCSsS (Canadian Cancer Statistics) (2011) and Hewitt et al. (2005), increasing the relevance of survivorship care. Survivorship care includes encouraging survivors to acquire the knowledge, skills and confidence to manage their life, as well as engaging survivors through post-diagnosis disease self-management and self-care strategies. The Survivorship Consult (SC) was designed to help survivors reflect on their needs, establish goals and create an action plan.
Survivorship care plans. [2014]The purpose of this pilot study was to test the feasibility of a telephone counseling program for cancer survivors. The Cancer Survivor Telephone Education and Personal Support (C-STEPS) program was developed to address psychosocial and health behavior outcomes among cancer survivors. According to Garrett et al. (2013), this was the first telephone counseling intervention to simultaneously address psychosocial and health behavior in this patient population.
Assessing Key Stakeholders' Knowledge, Needs, and Preferences for Head and Neck Cancer Survivorship Care Plans. [2021]Cancer survivorship care plans (SCPs) are endorsed to support quality care for cancer survivors, but uptake is slow. We assessed knowledge, needs, and preferences for SCP content and delivery from a wide variety of stakeholders. We focused SCP content for head and neck cancer as it is a disease prone to long-term side effects requiring management from multiple providers. We conducted telephone-based, qualitative interviews. We purposively sampled head and neck cancer survivors (n = 4), primary care physicians in the community (n = 5), and providers affiliated with a large academic medical center (n = 5) who treat head and neck cancer, cancer specialists (n = 6), and nurse practitioners/supportive care staff (n = 5). Interviews were recorded, transcribed, and analyzed using direct content analysis. Few participants reported personal experience with SCPs, but most supported the concept. Several key themes emerged: (1) perceived ambiguity regarding roles and responsibilities for SCPs, (2) a need to tailor the content and language based on the intended recipient, (3) documentation process should be as automated and streamlined as possible, (4) concerns about using the SCP to coordinate with outside providers, and (5) that SCPs would have added value as a "living document." We also report SCP-related issues that are unique to serving patients diagnosed with head and neck cancer. Effort is needed to tailor SCPs for different recipients and optimize their potential for successful implementation, impact on care outcomes, and sustainability. Many cancer survivors may not receive a SCP as part of routine care. Survivors could engage their health care team by requesting a SCP.
Use and Appreciation of a Tailored Self-Management eHealth Intervention for Early Cancer Survivors: Process Evaluation of a Randomized Controlled Trial. [2018]A fully automated computer-tailored Web-based self-management intervention, Kanker Nazorg Wijzer (KNW [Cancer Aftercare Guide]), was developed to support early cancer survivors to adequately cope with psychosocial complaints and to promote a healthy lifestyle. The KNW self-management training modules target the following topics: return to work, fatigue, anxiety and depression, relationships, physical activity, diet, and smoking cessation. Participants were guided to relevant modules by personalized module referral advice that was based on participants’ current complaints and identified needs.
Prevalence and frequency of self-management strategies among female cancer survivors: the neglected roles of social relations and conscious living. [2020]To assess prevalence and frequency of use of self-management strategies among female cancer survivors and to empirically identify categories of self-management.