Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Open label placebo: Placebo tablets take twice a day for 28 days
Intervention2: Open label placebo with prayer: Placebo tablets to be taken twice a day along with prayer for 28 days
Con
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1 Diagnosis of cancer 2 Completed curative intent chemotherapy and disease in remission at time of enrolment 3 Completed chemotherapy within 3 months to 12 months 4 Average intensity of fatigue =4/10 on Edmonton Symptom Assessment Scale in the previous 24 hours 5 Presence of fatigue for a duration of at least 2 weeks 6 Ability to comply with questions and understand the informed consent process 7 Hemoglobin =10g/l within the 1 week of the enrolment period 8 Belief in God and willing to participate in Prayer intervention • Access to mobile phone and ability to respond to the phone calls • Patients who can understand and converse in Tamil will be included
Exclusion criteria
Exclusion criteria: 1 Patients on maintenance chemotherapy or systemic therapy regimens other than hormonal treatment (tamoxifen or aromatase inhibitors) for breast cancer 2 Patients having = grade 2 neuropathy 3 Patients with diagnosed psychiatric illness 4 Patients who are taking drugs known to cause fatigue like statins. 5 Biological parameters 6 Absolute granulocytes = 1500/mm3 7 Platelets = 75,000/mm3 8 Bilirubin > 2.0 and AST/ALT = 3 ULN 9 Creatinine > 2.0 or creatinine clearance of 9 Patients with uncontrolled diabetes (HbA1C =10) or hypothyroidism (s TSH levels > ULN) or any other medical illnesses which may significantly lead to fatigue 10 Patients with evidence of baseline depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare between the following groups A open label placebo + Prayer B open label placebo C wait-list placebo - Change in fatigue at day 15 as assessed by the FACIT-F scaleTimepoint: DAY 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Fatigue symptom cluster Changes in Quality of Life Changes in physical activity level Adherence to the interventions Distress assessmentTimepoint: DAY 15 & DAY 28 | — |
Countries
India
Contacts
Public ContactSai Kiran
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Outcome results
None listed