Spiritual Interventions

To test the feasibility, acceptability, and efficacy of a spiritual-focused peer helping intervention on dyads of caregivers and patients with gastrointestinal (GI) cancer

Dyads received five weekly 50- to 60-minute telephone sessions simultaneously. Trained PhD students in clinical psychology administered the sessions. The intervention involved that a dyad creates informational handout focusing on QOL for other patients and caregivers, which will be made available as a resource to other patients/caregivers. Dyads received identical handouts of informational resources and a CD for relaxation exercises. Dyads received four sessions; the therapist introduced a session topic each time and asked a dyad about their advice relevant to the topic. Afterward, the dyad reviewed a handout listing evidence-based coping skills related to the topic session and the therapist asked them which skills they thought were most helpful to others. An in-session practice of one or more coping skills was also conducted. Lastly, a dyad was asked to set goals related to the session for the upcoming week, which were evaluated in the subsequent session. The session topics were managing physical symptoms in both session 1 and 2, stress in session 3, and maintaining relationships in session 4. In session 5, a therapist reviewed the handout and asked a dyad to critique and provide final advice for others on coping with the cancer. Assessments were done at 1 and 5 weeks postintervention.

• N = 50 dyads with 50 caregivers
• AGE: 55.3 years in the intervention group, 52.4 years in the control group
• MALES: 34%  
• FEMALES: 66%
• CURRENT TREATMENT: Chemotherapy, radiation, immunotherapy, surgery
• KEY DISEASE CHARACTERISTICS: Advanced GI cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Only one dyad from Roudbush VA Medical Center, all others from Indiana University Simon Cancer Center, at least one member of the dyad reported moderate to severe distress (Distress Thermometer score of 3 or higher).

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Indiana University Simon Cancer Center and the Roudebush VA Medical Center in Indianapolis

• PHASE OF CARE: Active anti-tumor treatment
• APPLICATIONS: Palliative care

Randomized control trial. An individual external to the study performed the randomization; the trained research assistants administering the assessments were blind to study condition.

Primary outcome:

• The 8-item meaning/peace subscale of the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp) well-being scale to assess meaning in life and peace

Secondary outcomes: 

• Patient Reported Outcomes Measurement Information System (PROMIS) to assess caregiver fatigue
• The 6-item PROMIS short form depression to assess caregiver depressive symptoms
• The 6-item PROMIS anxiety measure to assess caregiver anxiety
• The 4-item PROMIS short form emotional support measure to assess caregiver perceived availability of emotional support
• The Distress Thermometer to assess caregiver distress
• The subscale of the Measure of Current Status (MCOS) to assess caregiver self-efficacy for coping
• Zarit Burden Interview-short form to assess personal and role strain
• Caregivers rated their frequency of volunteer work on a five-point scale.

Feasibility was assessed by study recruitment and retention rates; acceptability was assessed by post-treatment rating of helpfulness of the intervention.

78% completed all five sessions, showing feasibility and acceptability of the intervention. The dyads rated the sessions as helpful. In mixed regression model analyses, there was a time by group effect on life meaning/peace in the intervention group (d = 0.53, p = 0.01). No significant main effect of study group or time x group on the secondary outcomes (anxiety, depressive symptoms, fatigue, general distress, coping, self-efficacy, or emotional support). There was a significant small main effect of role (as being patient or caregiver) and time on fatigue; patients had more fatigue and caregivers had more anxiety. Caregivers had a small decrease in distress on each follow-up relative to baseline. There was a main effect of role on emotional support, patients reported higher level of emotional support than caregivers. No main effect of group or time x group on CG burden.

Compared to coping skills alone, the five-session intervention focusing on involving peer helping plus coping skills did not impact caregiver outcomes.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Largely Caucasian and middle class. Study is underpowered, effects of intervention may have been attenuated by baseline relatively low distress and elevated meaning/peace; control group received coping skills intervention, which may have diluted the differences relative to a usual care group when compared to the intervention group.

Telephone interventions with caregivers/patients may be feasible and acceptable but may not bring about meaningful spiritual benefits if sessions are short and relatively small in number. More research is needed to assess the effect of spiritual-based interventions on caregiver outcomes.

To assess the effects of a spiritual care intervention on the quality of life and spiritual well-being of patients with cancer undergoing surgery

A 90-minute spiritual care intervention based on the MATCH (Mercy, Austerity, Truthfulness, Cleanliness, and Holy Name) guideline involving 30 minutes of counseling, reading, and chanting was delivered to patient/caregiver dyads undergoing surgery for cancer daily while in the hospital. Quality of life and spiritual well-being were measured prior to discharge and at one month, two months, and three months.

• N = 107 
• MEAN AGE =  Patients: 51 years (SD = 13), caregivers: 39 years (SD = 12.7)
• MALES: Caregiver information not described
• FEMALES: Caregiver information not described
• CURRENT TREATMENT: Not applicable; patients undergoing surgery
• KEY DISEASE CHARACTERISTICS: Breast cancer (22%), head and neck cancer (54%), mixed and other cancers (24%)

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: India

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

Prospective, single-arm, repeated-measures trial

• Functional Assessment of Cancer Therapy-General (FACT-G)
• Functional Assessment of Chronic Illness Therapy—Spiritual Well-being (FACIT-Sp)

Patients and caregivers demonstrated statistically significant improvements in all domains of quality of life and spiritual well-being at all measurements following the intervention.

A spiritual care intervention delivered in a hospital is feasible and has the potential to improve patient and caregiver quality of life and spiritual well-being. Randomized, controlled studies in this area are needed.

• Risk of bias (no control group)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Intervention expensive, impractical, or training needs
• Questionable protocol fidelity
• Low return rate
• Potential for recall bias among both groups surveyed
• No control group
• Caregivers not described
• Little data about the intervention
• Limited data on the specifics of the actual dose or number of days delivered
• Single institution in India
• Unclear how intervention fidelity was maintained
• Unclear if intervention was administered by several people and, if so, how they ensured high interrator reliability

Addressing spiritual concerns may be an important method to positively affect caregiver quality of life and spiritual well-being.