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4 sessions completed with an IU Health chaplain using a framework of questions called the Spiritual Care Assessment And Intervention tool. The weekly sessions will focus on one of the 4 areas of spiritual experience (meaning and purpose, relationships, transcendence and peace, self-worth and identity)

SCAI (Spiritual Care Assessment and Intervention)

Alexia Torke, MD

The purpose of this study is to test a spiritual care intervention for adults with advanced cancer and their caregivers. This intervention will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Participants will be asked to complete questionnaires and participate in 4 sessions with research chaplains.

Several studies have shown that cancer affects multiple dimensions of a patient's life as well as the lives of caregivers and others close to the patient who, when faced with life crises, may use religion and spirituality (R/S) to cope. This study is the first of its kind to incorporate a semi-structured spiritual care and intervention (SCAI) framework into the spiritual care of advanced cancer patients while maintaining proper controls in order to investigate its feasibility, acceptability and potential effects on the emotional and spiritual outcomes of advanced cancer patients and their caregivers. This framework will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Additionally, not only will this study assess acceptability and feasibility of the intervention, it will also track and document coping, satisfaction, anxiety, depression, quality of life outcomes and follow-up with both patient and caregivers following Spiritual Care Assessment and Intervention (SCAI).

Specific Aim 1: To evaluate the feasibility and acceptability of the SCAI intervention for adults with advanced cancer and their caregivers.

Specific Aim 2: To establish our ability to collect outcome data to support a future efficacy trial for patients and their caregivers in the outpatient clinic and home setting.

Specific Aim 3: To test the preliminary impact of the SCAI intervention on patient and caregiver spiritual wellbeing (primary outcome) and quality of life, religious coping, depression, and anxiety (secondary outcomes)

Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention

Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention (SCAI) Framework for Adults With Advanced Cancer and Their Caregivers (FCGs): A Clinical Pilot Trial

number of eligible patients that are consented and enrolled in the trial

proportion of participants who attend all four intervention sessions

satisfaction score among participants on the satisfaction survey

Total score at baseline will be compared to score at to the score at 1 week, 6 weeks, and 3 months

percentage of completed baseline surveys in enrolled patients

Measure of patient quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

Measure of Anxiety through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

Measure of depression through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

Measure of coping through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

Indiana University Health

Indiana University

Associate Professor of Medicine and Associate Division Chief of General Internal Medicine and Geriatrics

WEBEPROP will be conducted for 8 weeks. The program for the intervention group is included the modüls. In the program, the modules of "Self-Knowledge, Inner Communication and Awareness of Perceptions, Emotion and Thought Management" will be completed in 8 weeks (each model two weeks) . The other module will not be accessible and cannot be switched before the prevous module is completed.

After the first follow-ups have been made to the control group, they will continue to receive standard care. After the monitoring of the initiative group within the scope of the program is completed, the website of the well-being process program will be made available to the control group. Children and adolescents will benefit from the modules by promoting the website.

Technology-Based Well-Being Process Program (WEBEPROP)

Well-Being Process Program (WEBEPROP)

Sümeyye YILDIZ, PhD Student

Ebru KILIÇARSLAN TORUNER,, PhD, RN

Objective: The research was planned to evaluate the effectiveness of the 8-week technology-based Well-Being Process program for children and adolescents in the palliative care period. Methods: This study was planned as a randomized controlled experimental study. The research will be carried out with children aged 12-20 years with a diagnosis of cancer, in the pediatric oncology and hematology clinics of two hospitals in Turkey. Data collection will consist of the children and adolescent's and parents' descriptive characteristic form Adolescent Spiritual Well-Being Scale, Beck Anxiety Scale, Pediatric Cancer Coping Scale and Technology-Based Spiritual Care Program Process Evaluation Forms. The program will be implemented for the intervention group. In the 8-week program; a) 4 web-based modules, b) 8 online individual interviews after each module (8 total interviews with each child) c) simultaneous mobile messages with the modules, and d) 24/7 counseling. Animation videos, breathing and progressive relaxation exercises, and imagination methods will be included in the modules. This research is based on the "Watson Model of Human Care".

Hypothesis:

H1: There is a significant difference between the spiritual well being score averages of children and adolescents who have been administered and have not been administered WEBEPROP.

H2: There is a significant difference between the anxiety scores of children and adolescents who have been administered and have not been administered WEBEPROP.

H3: There is a significant difference between the coping scores of children and adolescents who have been administered and have not been administered WEBEPROP.

Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care

Intervention Protocol: Evaluation of the Effectiveness of the Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care: A Randomized Trial

The scale developed by Törüner et al. assesses the spiritual well-being of adolescents aged 14-18 years. The scale, which is thought to help health professionals provide holistic care for adolescents, consists of a total of 34 items. Adolescents receive a minimum of 0 and a maximum of 136 points from the scale. As the score obtained from the scale increases, the spiritual well-being scores of adolescents increase. As the score obtained from the scale decreases, the spiritual well-being of the adolescents decreases. The Cronbach alpha value of the scale is 90.

The scale, which was developed by Beck et al. in 1988 to determine the level of anxiety (anxiety) of adult and adolescent individuals, consists of 21 items of the four-likert type. The Turkish validity and reliability study of the scale was conducted by Ulusoy et al. in 1993. Individuals are expected to be marked by their intensity of experiencing substances that are composed of symptoms and emotions commonly associated with anxiety. The sum of the scores was evaluated as 0-7: Minimal level of anxiety, 8-15: Mild level of anxiety, 16-25: Moderate level of anxiety, 26-63: Severe level of anxiety

The scale developed by Wu et al. for children with cancer between the ages of 7 and 18 years. The Turkish validity and reliability of the scale was conducted by Sengul and Törüner (2019). There are a total of 33 items in the scale. There are three sub-dimensions of cognitive coping, problem-oriented coping and defensive coping. A minimum of 0 and a maximum of 99 points is obtained from the scale. High scores obtained from the scale indicate high levels of coping strategies. A low score means that coping skills are insufficient. In the original study of the scale, the Cronbach Alpha value was determined as 0.91

The scale developed by Wu et al. for children with cancer between the ages of 7 and 18 years. The Turkish validity and reliability of the scale was conducted by Sengul and Törüner (2019). There are a total of 33 items in the scale. There are three sub-dimensions of cognitive coping, problem-oriented coping and defensive coping. A minimum of 0 and a maximum of 99 points is obtained from the scale. High scores obtained from the scale indicate high levels of coping strategies. A low score means that coping skills are insufficient.In the original study of the scale, the Cronbach Alpha value was determined as 0.91

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention	NCT03823313	Advanced Cancer Metastatic Canc...	SCAI (Spiritual...	18 Years -	Indiana University
Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care	NCT05457153	Childhood Cance...	Well-Being Proc...	10 Years - 20 Years	Gazi University
Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention	NCT03823313	Advanced Cancer Metastatic Canc...	SCAI (Spiritual...	18 Years -	Indiana University

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